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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)
Applicant
Polyremedy, Inc.
49 Coastal Oak
Aliso Viejo,  CA  92656
Applicant Contact GARY MOCNIK
Correspondent
Polyremedy, Inc.
49 Coastal Oak
Aliso Viejo,  CA  92656
Correspondent Contact GARY MOCNIK
Classification Product Code
FRO  
Date Received05/23/2012
Decision Date 06/27/2012
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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