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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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clicker BIOJECT, INC. k994384 06/22/2000
cloud cuff PARTS PORT, LTD. k002360 09/26/2000
cobe hvr 2200 hardshell venous reservoir, filtered COBE CARDIOVASCULAR, INC. k994389 03/27/2000
cocaine metabolite intercept micro-plate eia ORASURE TECHNOLOGIES, INC. k001197 05/11/2000
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
comfort control syringe system DENTSPLY INTL. k002387 09/28/2000
conchatherm 2000 humidification system, models 500-00, -10, -20, -30, -40, -50, & -60 HUDSON RESPIRATORY CARE, INC. k001213 11/03/2000
connect data management system ABBOTT DIABETES CARE INC. k994433 05/05/2000
convertors equipment drapes ALLEGIANCE HEALTHCARE CORP. k000417 03/17/2000
cook ivf follicle flushing buffer, cook ivf oocyte wash buffer, cook ivf fertilization medium, cook ivf cleavage medium, COOK OB/GYN k002385 09/18/2000

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