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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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clearwater colon hydrotherapy (disposable speculum spo1 large & sp02 small) CLEARWATER COLON HYDROTHERAPY, INC. k000388 08/08/2000
cn acquisition station CARDIONOW, INC. k002597 11/17/2000
cobas amplicor ct/ng test for neisseria gonorrhoeae ROCHE DIAGNOSTICS CORP. k053289 08/10/2006
cobe smarxt vvr 4000 filtered hardshell venous reservoir COBE CARDIOVASCULAR, INC. k002591 09/13/2000
cobra cooled cardiac surgical probe, model 1596x BOSTON SCIENTIFIC CORP. k023291 10/17/2002
codman vpv system, model 82-3192 Codman & Shurtleff, Inc. k061876 10/16/2006
comoact ultrasonic nebulizer, model 3060 SAN UP S.A. k002543 06/14/2001
compress segmental femoral replacement system BIOMET, INC. k043547 08/05/2005
contempro-mist CONTEMPORARY PRODUCTS, INC. k000543 06/16/2000
cook pressure monitoring catheter COOK, INC. k002254 03/16/2001

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