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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 K113836
FOIA Releasable 510(k) K113836
Device Name BENEHOLD CHG TRANSPARENT FILM DRESSING (10X12CM) (8.5X12CM) (6.5X7 CM)
Applicant
Avery Dennison Belgie Bvba
20 N. Wacker Dr., Suite 2240
Chicago,  IL  60606
Applicant Contact JERZY WOJCIK
Correspondent
Avery Dennison Belgie Bvba
20 N. Wacker Dr., Suite 2240
Chicago,  IL  60606
Correspondent Contact JERZY WOJCIK
Classification Product Code
FRO  
Date Received12/28/2011
Decision Date 09/24/2012
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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