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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 K152519
FOIA Releasable 510(k) K152519
Device Name MTR550 (Tentative) Antimicrobial Silver Wound Gel
Applicant
Medical Technology Research, Inc.
2650 Progress Way
Woodburn,  OR  97071
Applicant Contact Bhalchandra M. Karandikar
Correspondent
Medical Technology Research, Inc.
2650 Progress Way
Woodburn,  OR  97071
Correspondent Contact Bhalchandra M. Karandikar
Classification Product Code
FRO  
Date Received09/03/2015
Decision Date 06/02/2016
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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