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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
Models MED9803S, MED9804S, MED9805S
Device Name BENEHOLD CHG TRANSPARENT FILM DRESSING (10X12CM) (8.5X12CM) (6.5X7 CM)
Original Applicant
AVERY DENNISON BELGIE, BVBA
20n. wacker drive
suite 2240
chicago,  IL  60606
Original Contact jerzy wojcik
Classification Product Code
FRO  
Date Received12/28/2011
Decision Date 09/24/2012
Decision substantially equivalent (SE)
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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