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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 K103141
Device Name LOW ADHERENT AFM AG DRESSINGS
Applicant
Milliken Healthcare Products, LLC
11440 W. Bernardo Ct.
Suite 300
San Diego,  CA  92127
Applicant Contact RONALD S WARREN, RAC
Correspondent
Milliken Healthcare Products, LLC
11440 W. Bernardo Ct.
Suite 300
San Diego,  CA  92127
Correspondent Contact RONALD S WARREN, RAC
Classification Product Code
FRO  
Date Received10/25/2010
Decision Date 01/21/2011
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product Yes
Predetermined Change
Control Plan Authorized		 No
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