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Date of Notification
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Title
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FSN
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31 Jul 2017
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ADVIA Centaur T3, Siemens Healthcare Diagnostics Inc. (HSA 600:41/01-022/17/23_60)
Local Contact: Siemens Healthcare Pte. Ltd.
Contact no./Email: ui-handling.sg.dl@siemens-healthineers.com
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HSA 6004101-022-17-23_60 FSN220 KB
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31 Jul 2017
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Zimmer A.T.S. (Autotmatic Torniquet System) 2200TS and 4000TS, Zimmer Surgical, Inc (HSA 600:41/01-008/17/09_46)
Local Contact: Zimmer Pte Ltd
Contact no./Email: 6854 7250
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HSA 6004101-008-17-09_46 FSN_Redacted248 KB
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31 Jul 2017
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PneumoCryoprobe; Flexible, Erbe Elektromedizin GmbH (HSA 600:41/01-312/17/01_48)
Local Contact: Erbe Singapore Pte Ltd
Contact no./Email: 6562 8345
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HSA 6004101-312-17-01_48 FSN_Redacted142 KB
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31 Jul 2017
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Advance XP Male Sling System, Boston Scientific (HSA 600:41/01-142/17/01_54)
Local Contact: Mediconsult Asia Pte Ltd
Contact no./Email: 6483 2370
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HSA 6004101-142-17-01_54 FSN_Redacted319 KB
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28 Jul 2017
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Siemens Dimension® Alanine Aminotranferase (ALTI) Flex® reagent cartridge, Siemens ADVIA Chemistry 1800, 2400, XPT Ammonia (AMM), Siemens ADVIA Chemistry 1800, 2400, XPT Alanine Aminotransferase (ALT), Siemens ADVIA Chemistry 1800, 2400, XPT Salicylate (SAL), Siemens Dimension® Aspartate Aminotransferase (AST) Flex® reagent cartridge, Siemens Dimension® Glucose Flex® reagent cartridge (GLUC), Siemens Syva® Emit® 2000 Tacrolimus Sample Pretreatment Reagents/Syva® Emit® 2000 Tacrolimus Calibrators/Syva® Emit® 2000 Tacrolimus Assay, Siemens Healthcare Diagnostics, Inc (HSA 600:41/01-022/17/22_59)
Local Contact: Siemens Healthcare Pte Ltd
Contact no./Email: ui-handling.sg.dl@siemens-healthineers.com
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HSA 6004101-022-17-22_59_FSN68 KB
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28 Jul 2017
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AIRO Mobile CT Scanner, BrainLab AG (HSA 600:41/01-047/17/02_46)
Local Contact: BrainLab Limited (Singapore Branch)
Contact no./Email: 6734 1701 / sg.sales@brainlab.com
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HSA 6004101-047-17-02_46 FSN_Redacted375 KB
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27 Jul 2017
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BD Multitest CD3/CD8/CD45/CD4, Becton, Dickinson and Company (BD) (HSA 600:41/01-003/17/15_58)
Local Contact: Becton Dickinson Holdings Pte. Ltd. (BD)
Contact no./Email: 6432 2048
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HSA 6004101-003-17-15_58 FSN_Redacted48 KB
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26 Jul 2017
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VersaSafe Plastic Cannula – 11 Gauge, CareFusion 303 Inc (HSA 600:41/01-003/17/14_25)
Local Contact: Becton Dickinson Holdings Pte Ltd (BD)
Contact no./Email: 6432 2048
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HSA 6004101-003-17-14_25 FSN_Redacted2744 KB
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25 Jul 2017
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Percuvance® Percutaneous Surgical System, Teleflex Medical (HSA 600:41/01-139/17/02_43)
Local Contact: Teleflex Medical Asia Pte Ltd
Contact no./Email: 6439 3043
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HSA 6004101-139-17-02_43 FSN_Redacted172 KB
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20 Jul 2017
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Vertaplex, Spineplex IVS cement and cement containing kits, Stryker Instruments (HSA 600:41/01-014/17/04_51)
Local Contact: Stryker Singapore Pte Ltd
Contact no./Email: ASEAN.PMS@stryker.com
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HSA 6004101-014-17-04_51 FSN_Redacted101 KB
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20 Jul 2017
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Proteus 235 - Proton Therapy System, Ion Beam Applications S.A. (HSA 600:41/01-070/17/12_51)
Local Contact: Transmedic Pte Ltd
Contact no./Email: 6477 6101 / regulatory@transmedicgroup.com
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HSA 6004101-070-17-12_51 FSN_Redacted301 KB
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20 Jul 2017
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HomeChoice Automated PD Cycler, 230V; HomeChoice PRO Automated PD Cycler, 230V, Baxter Healthcare SA (HSA 600:41/01‐001/17/03_44)
Local Contact: Baxter Healthcare (Asia) Pte. Ltd.
Contact no./Email: 6826 2616
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HSA 6004101-001-17-03_44 FSN_Patient Letter_Redacted2194 KB
HSA 6004101-001-17-03_44 FSN_Center Letter_Redacted21142 KB
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19 Jul 2017
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Leica M525 F40 Surgical Microscopes, Leica Microsystems (Schweiz) AG (HSA 600:41/01-126/17/02_40)
Local Contact: Leica Microsystems (SEA) Pte Ltd
Contact no./Email: 6550 5999 / singapore@leica-microsystems.com
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HSA 60041-01-126-17-02_40 FSN_Redacted346 KB
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19 Jul 2017
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Alere HIV Combo, Alere Medical Co. Ltd (HSA 600:41/01-111/17/02_38)
Local Contact: Unison Collaborative Pte Ltd
Contact no./Email: 6734 5577 / info@unicoll.com.sg
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HSA 6004101-111-17-02_38 FSN72 KB
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19 Jul 2017
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SMARTABLATE™RF GENERATOR SYSTEM, Biosense Webster Inc (HSA 600:41/01-002/17/08_36)
Local Contact: Johnson & Johnson Pte Ltd
Contact no./Email: 6918 7781
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HSA 6004101-002-17-08_36 FSN_Redacted105 KB
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18 Jul 2017
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CS100IABP, CS300IABP, Datascope Corp (HSA 600:41/01-081/17/02_35)
Local Contact: Maquet South East Asia Pte Ltd
Contact no./Email: 6296 1992
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HSA 6004101-081-17-02_35 FSN_Redacted106 KB
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18 Jul 2017
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cobas c 501 module & cobas c 502 module, Roche Diagnostics GmbH (HSA 600:41/01-016/17/14_34)
Local Contact: Roche Diagnostics Asia Pacific Pte Ltd
Contact no./Email: sg.regulatory@roche.com
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HSA 6004101-016-17-14_34 FSN210 KB
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17 Jul 2017
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Mueller Hinton E Agar (MHE), bioMérieux SA (HSA 600:41/01-146/17/09_31)
Local Contact: BioMerieux Singapore Pte Ltd
Contact no./Email: 6801 6700
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HSA 6004101-146-17-09_31 FSN314 KB
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17 Jul 2017
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SPINOUS PROCESS CLAMPS, Medtronic Navigation, Inc (HSA 600:41/01-009/17/15_19)
Local Contact: Medtronic International Ltd.
Contact no./Email: 6439 6932
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HSA 6004101-009-17-15_19 FSN_Redacted1335 KB
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14 Jul 2017
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VITROS Chemistry Products Performance Verifier II, Ortho-Clinical Diagnostics Inc (HSA 600:41/01-303/17/09_31)
Local Contact: ORTHO-CLINICAL DIAGNOSTICS SINGAPORE PTE. LTD
Contact no./Email: 6486 1151
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HSA 6004101-303-17-09_31 FSN_Redacted210 KB
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14 Jul 2017
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VITEK® 2 Compact, bioMérieux, Inc. (HSA 600:41/01-146/17/08_60)
Local Contact: BioMerieux Singapore Pte Ltd
Contact no./Email: 6801 6706
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HSA 6004101-146-17-08_60 FSN295 KB
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14 Jul 2017
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Absorb and Absorb GT1 Bioresorbable Vascular Scaffold (BVS) Systems, Abbott Vascular (HSA 600:41/01-005/17/10_35)
Local Contact: Abbott Laboratories Singapore Pte Ltd
Contact no./Email: 6914 8000; FSN_Enquiry@abbott.com
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HSA 6004101-005-17-10_35 FSN59 KB
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14 Jul 2017
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Medtronic MyCareLink™ Remote Monitors, Medtronic Inc (HSA 600:41/01-009/17/14_25)
Local Contact: Medtronic International Limited
Contact no./Email: 6436 5077
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HSA 6004101-009-17-14_25 FSN_Redacted289 KB
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13 Jul 2017
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ARJOHUNTLEIGH FLOWTRON ACS900, ArjoHuntleigh AB (HSA 600:41/01-065/17/01_64)
Local Contact: ArjoHuntleigh Singapore Pte Ltd
Contact no./Email: Phone: 6293 3387
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HSA 6004101-065-17-01_64 FSN_Redacted134 KB
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13 Jul 2017
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Euphora Rapid Exchange Balloon Dilatation Catheters, Medtronic Inc (HSA 600:41/01-009/17/13_46)
Local Contact: Medtronic International Limited
Contact no./Email: 6436 5077
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HSA 6004101-009-17-13_46 FSN_Redacted106 KB
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12 Jul 2017
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CARESCAPE Patient Data Module (PDM) on CARESCAPE B850/650/450, GE Medical Systems Information Technologies Inc. (HSA 600:41/01-010/17/04_36)
Local Contact: GE Healthcare Pte Ltd
Contact no./Email: 6277 3553; svc@ge.com
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HSA 6004101-010-17-04_36 FSN_Redacted72 KB
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11 Jul 2017
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Gambro AK 98 Dialysis Machine, Gambro Lundia AB (HSA 600:41/01-001/17/02_63)
Local Contact: Baxter Healthcare (Asia) Pte. Ltd.
Contact no./Email: Tel: 6826 2616
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HSA 6004101-001-17-02_63 FSN_Redacted2458 KB
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11 Jul 2017
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SYNCHRON® System(s) Salicylate (SALY), Beckman Coulter Inc. (HSA 600:41/01-052/17/09_67)
Local Contact: Beckman Coulter Singapore Pte Ltd
Contact no./Email: 6340 7126
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HSA 6004101-052-17-09_67 FSN_Redacted101 KB
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10 Jul 2017
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Automated Digital Cell Morphology Analyzer DI-60, CellaVision AB (HSA 600:41/01-032/17/01_65)
Local Contact: Sysmex Asia Pacific Pte Ltd
Contact no./Email: 6221 3629 / RA@sysmex-ap.com
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HSA 6004101-032-17-01_65 FSN_Redacted1218 KB
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07 Jul 2017
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OPTI CCA B-Lac Cassette, OPTI Medical Systems, Inc. (HSA 600:41/01-033/17/04_60)
Local Contact: Biomed Diagnostics Pte Ltd
Contact no./Email: 6298 4347 / biomed.regulatory@biomed-global.com
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HSA 6004101-033-17-04_60 FSN49 KB
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07 Jul 2017
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Set 9734378 Supplemental Ins Axiem Ent, Medtronic Navigation, Inc (HSA 600:41/01-009/17/12_50)
Local Contact:Medtronic International Ltd
Contact no./Email: 6436 5000
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HSA 6004101-009-17-12_50 FSN_Redacted2074 KB
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06 Jul 2017
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LipiFlow System Activator (Disposable), TearScience Inc (HSA 600:41/01-110/17/02_40)
Local Contact:Mandarin Opto-Medic Co Pte Ltd
Contact no./Email: 6747 8777 / manopt@mandarinoptomedic.com
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HSA 60041-01-110-17-02_40 FSN417 KB
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06 Jul 2017
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Microgenics Multigent Quinidine Assay, Microgenics Corporation (HSA 600:41/01-005/17/09_58)
Local Contact: Abbott Laboratories Pte Ltd
Contact no./Email: 6941 8000 /FSN@enquiry@abbott.com
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HSA 60041-01-005-17-09_58 FSN_Redacted195 KB
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06 Jul 2017
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Boston Scientific ILab Ultrasound Imaging System (FFR Link), Boston Scientific Corporation (HSA 600:41/01-007/17/08_48)
Local Contact: Boston Scientific Asia Pacific Pte Ltd
Contact no./Email: 6418 8888; Singapore_FSCA_Query@bsci.com
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HSA 6004101-007-17-08_48 FSN_Redacted236 KB
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05 Jul 2017
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Galaxy Unyco Diaphyseal Tibia Sterile Kit, OrthoFix Srl (HSA 600:41/01-115/17/01_44)
Local Contact: Opto Systems (S) Pte Ltd
Contact no./Email: 6296 2881
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HSA 6004101-115-17-01_44 FSN_Redacted156 KB
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05 Jul 2017
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Roche Diagnostics cobas e 602, cobas e 601 and E170 modules, Roche Diagnostics GmbH (HSA 600:41/01-016/17/12_58)
Local Contact:Roche Diagnostics Asia Pacific Pte Ltd
Contact no./Email: sg.regulatory@roche.com
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HSA 6004101-016-17-12_58 FSN2195 KB
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03 Jul 2017
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Novopen Echo, Novo Nordisk A/S (HSA 600:41/01-311/17/01_49)
Local Contact: Novo Nordisk Pharma (Singapore) Pte Ltd
Contact no./Email: mysafety@novonordisk.com, SGAGREE1@novonordisk.com
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HSA 6004101-311-17-01_49_HCPs FSN_Redacted144 KB
HSA 6004101-311-17-01_49_Pharmacies FSN_Redacted133 KB
HSA 6004101-311-17-01_49_patients FSN_Redacted78 KB
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15 Feb 2017
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Bio-Rad DiaMed ID-Card LISS/Coombs, DiaMed GmbH (HSA 600:41/01-027/17/02_60)
Local Contact: Bio-Rad Laboratories (Singapore) Pte Ltd
Contact no./Email: 6490 4262
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HSA 6004101-027-17-02_60 FSN Part 3_Redacted5269 KB
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