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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 K092351
FOIA Releasable 510(k) K092351
Device Name POLY FIT + ABSORBING AND HIGH ABSORBING ANTIMICROBIAL DRESSINGS
Applicant
Polyremedy, Inc.
24372 Mccloud Ct.
Laguna Niguel,  CA  92677
Applicant Contact GARY MOCNIK
Correspondent
Polyremedy, Inc.
24372 Mccloud Ct.
Laguna Niguel,  CA  92677
Correspondent Contact GARY MOCNIK
Classification Product Code
FRO  
Date Received08/04/2009
Decision Date 04/08/2010
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product Yes
Predetermined Change
Control Plan Authorized		 No
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