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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name dressing, wound, drug
510(k) Number K121275
Device Name AQUACEL AG EXTRA HYDROFIBER DRESSING WITH SILVER AND STRENGTHENING FIBER
Original Applicant
CONVATEC INC
200 headquarters park drive
skillman,  NJ  08558
Original Contact katrina fiedler
Classification Product Code
FRO  
Date Received04/27/2012
Decision Date 07/25/2012
Decision substantially equivalent (SE)
Classification Advisory Committee General & Plastic Surgery
Review Advisory Committee General & Plastic Surgery
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product Yes
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