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U.S. Department of Health and Human Services

510(K) Premarket Notification
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Device Name
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510(K)
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Decision
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qualitrol dhp immunoassay control, levels 1,2, and 3 CONSOLIDATED TECHNOLOGIES OF WISCONSIN k001249 11/02/2000
aps series dialyzers (wet models), aps series dialysis (dry models) ASAHI MEDICAL CO., LTD. k001250 08/16/2000
sniper, model or-3872xx series NIPRO MEDICAL CORP. k001251 07/07/2000
maxhealth wheelchair, model he-8631, he-8621, he-8651 MAXHEALTH CORP. k001252 06/12/2000
surgitron iec ii ELLMAN INTL., INC. k001253 05/26/2000
orthomatrix, inc. cerclage system ORTHOMATRIX, INC. k001254 12/13/2000
cd horizon spinal system MEDTRONIC SOFAMOR DANEK, INC. k001255 07/11/2000
control plasma n DADE BEHRING, INC. k001256 05/24/2000
intracoil stent INTRATHERAPEUTICS, INC. k001257 05/18/2000
bx transhepatic biliary stent and delivery system CORDIS CORP. k001258 06/27/2000

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