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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 K121522
Device Name POLYFIT ABSORBING ANTIMICROBIAL DRESSINGS (OTC)
Original Applicant
POLYREMEDY, INC.
49 coastal oak
aliso viejo,  CA  92656
Original Contact gary mocnik
Classification Product Code
FRO  
Date Received05/23/2012
Decision Date 06/27/2012
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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