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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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clirans e-series dialyzer TERUMO MEDICAL CORP. k013550 11/20/2001
collatek powder BIOCORE MEDICAL TECHNOLOGIES, INC. k012990 10/24/2001
color buffed (cb) ddh femoral stem BIOMET, INC. k012019 07/20/2001
compass esophageal pressure catheter, model gie-8500, compass ano-rectal pressure catheter, model gia-8500 CLINICAL INNOVATIONS, INC. k022023 01/07/2003
compressible limb sleeve MEDICAL DEVICE SERVICES, INC. k012979 05/08/2002
cooltouch varizoom NEW STAR LASERS, INC. k012982 10/02/2001
coulter cellprep BECKMAN COULTER, INC. k021150 06/11/2002
critertion, model #1067511 STERNGOLD k021741 06/26/2002
cryobag, model cb ORIGEN BIOMEDICAL, INC. k021702 08/06/2002
d/sense 1-step CENTRIX, INC. k021146 07/02/2002

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