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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 K042164
Device Name SILVER ANTIMICROBIAL WOUND GAUZE (SPONGE)
Applicant
Medline Industries, Inc.
12232 SW Garden Pl.
Portland,  OR 
Applicant Contact BRUCE GIBBINS
Correspondent
Medline Industries, Inc.
12232 SW Garden Pl.
Portland,  OR 
Correspondent Contact BRUCE GIBBINS
Classification Product Code
FRO  
Date Received08/11/2004
Decision Date 06/09/2005
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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