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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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Applicant
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510(K)
Number
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Decision
Date
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freestyle blood glucose monitoring system, cat no 11001 ABBOTT DIABETES CARE INC. k000582 12/05/2000
dideco micro 40 ph.i.s.i.o (phosphorylcholine insert surface in oxgenation) newborn/infant arterial filter COBE CARDIOVASCULAR, INC. k002493 11/30/2000
alliance left heart delivery system introducer, model #407509 DAIG CORP. k000004 11/29/2000
comfit chemo plus powder free blue nitrile examination gloves, non sterile (tested for use with chemotherapy drug) label WRP ASIA PACIFIC SDN. BHD. k002064 11/28/2000
bio-rad %cdt tia AXIS-SHIELD BIOCHEMICALS, ASA k001651 11/22/2000
front-load polypropylene syringe MEDRAD, INC. k001663 11/16/2000
amt spinal system MICRON PRECISION ENGINEERING, INC. k002059 11/13/2000
samsung 10dr implant system SAMSUNG SDS CO., LTD k002062 11/09/2000
lumboperitoneal shunt system PHOENIX BIOMEDICAL CORP. k002476 11/09/2000
precimed trauma system PATRICK BERDOZ k002486 11/09/2000

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