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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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comprehensive primary shoulder stems BIOMET MANUFACTURING CORP. k060692 05/30/2006
connect data management system ABBOTT DIABETES CARE INC. k994433 05/05/2000
contoured articular prosthesis (cap) humeral head resurfacing system STD MFG., INC. k023096 04/10/2003
convertors surgical gowns, sterile ALLEGIANCE HEALTHCARE CORP. k994244 02/18/2000
convey guiding catheter PENDRACARE INTERNATIONAL, B.V. k120585 08/08/2012
corin adaptor sleeve HOWMEDICA OSTEONICS CORP k071471 09/10/2007
cozart eia cotinine urine kit COZART BIOSCIENCE LTD. k021944 05/14/2003
cp peripheral angio array coil/ magnetom symphony system SIEMENS MEDICAL SOLUTIONS USA, INC. k994315 02/04/2000
critertion, model #1067511 STERNGOLD k021741 06/26/2002
custom comfort nightguard version 2 DENTEK ORAL CARE, INC. k091660 06/12/2009

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