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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 K093188
Device Name AFM ULTRA AG DRESSINGS
Applicant
Milliken & Co.
49 Plain St.
North Attleboro,  MA  02760
Applicant Contact MARY MCNAMARA-CULLINANE
Correspondent
Milliken & Co.
49 Plain St.
North Attleboro,  MA  02760
Correspondent Contact MARY MCNAMARA-CULLINANE
Classification Product Code
FRO  
Date Received10/09/2009
Decision Date 02/17/2010
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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