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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
FOIA Releasable 510(k) K121275
Device Name AQUACEL AG EXTRA HYDROFIBER DRESSING WITH SILVER AND STRENGTHENING FIBER
Applicant
Convatec, Inc.
200 Headquarters Park Dr.
Skillman,  NJ  08558
Applicant Contact KATRINA FIEDLER
Correspondent
Convatec, Inc.
200 Headquarters Park Dr.
Skillman,  NJ  08558
Correspondent Contact KATRINA FIEDLER
Classification Product Code
FRO  
Date Received04/27/2012
Decision Date 07/25/2012
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product Yes
Predetermined Change
Control Plan Authorized		 No
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