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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 K030083
Device Name VAXCEL WITH PASV PORT
Original Applicant
BOSTON SCIENTIFIC CORP.
10 glens falls technical park
glens falls,  NY  12801 3864
Original Contact jodi lynn greenizen
Regulation Number880.5965
Classification Product Code
LJT  
Date Received01/09/2003
Decision Date 01/28/2003
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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