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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 K032375
Device Name VAXCEL PORT, MODELS 45-336 AND 45-338
Original Applicant
10 glens falls technical park
glens falls,  NY  12801 -3864
Original Contact jodi lynn greenizen
Regulation Number880.5965
Classification Product Code
Date Received08/01/2003
Decision Date 08/19/2003
Decision substantially equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
summary summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls