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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name port & catheter, implanted, subcutaneous, intravascular
510(k) Number K032008
Device Name VAXCEL WITH PASV PORT, MODEL 45-213
Original Applicant
BOSTON SCIENTIFIC CORP.
one boston scientific place
natick,  MA  01760
Original Contact jodi lynn greenizen
Regulation Number880.5965
Classification Product Code
LJT  
Date Received07/01/2003
Decision Date 07/14/2003
Decision substantially equivalent (SE)
Classification Advisory Committee General Hospital
Review Advisory Committee General Hospital
summary summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
Recalls CDRH Recalls
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