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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 K141603
FOIA Releasable 510(k) K141603
Device Name Ultra Silver Dressings
Applicant
Milliken Healthcare Products, LLC
62 Forest St., Suite 300
Marlborough,  MA  01752
Applicant Contact GORDON MACFARLANE
Correspondent
Milliken Healthcare Products, LLC
62 Forest St., Suite 300
Marlborough,  MA  01752
Correspondent Contact GORDON MACFARLANE
Classification Product Code
FRO  
Date Received06/16/2014
Decision Date 10/22/2014
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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