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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 K160695
Device Name Talymed Suspension
Applicant
Marine Polymer Technologies, Inc.
107 Water St.
Danvers,  MA  01923
Applicant Contact Sergio Finkielsztein
Correspondent
Marine Polymer Technologies, Inc.
107 Water St.
Danvers,  MA  01923
Correspondent Contact Sergio Finkielsztein
Classification Product Code
FRO  
Date Received03/14/2016
Decision Date 12/06/2016
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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