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U.S. Department of Health and Human Services

510(K) Premarket Notification

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510(K)
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Decision
Date
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arm blood pressure monitor, models kp-6821, kp-6822 K-JUMP HEALTH CO., LTD. k014204 03/05/2002
modification to bridge self-expanding biliary stent delivery system (bridge se) MEDTRONIC AVE, INC. k014205 01/14/2002
logiqbook GENERAL ELECTRIC CO. k014206 01/16/2002
sterile powder free latex surgeon gloves with protein labeling claim (50 microgram or less) SUPERMAX GLOVE MANUFACTURING SDN BHD k014230 03/13/2002
orthopaedic innovations renewal acetabular cup system ORTHOPAEDIC INNOVATIONS, INC. k020145 04/15/2002
serralnyl SERRAL, S.A. DE C.V. k020146 04/15/2002
magellan ratio dispenser kit/magellan spray tip/magellan cannula tip MEDTRONIC PERFUSION SYSTEMS k020147 04/03/2002
phoenix ise reagents for olympus au chemistry systems PHOENIX DIAGNOSTICS, INC. k020148 02/04/2002
crc-15bt CAPINTEC, INC. k020150 08/02/2002
ud-1000 ultrasonic a/b scanner TOMEY CORP. USA k020151 04/10/2002

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