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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 K102002
Device Name TALYMED
Applicant
Marine Polymer Technologies
107 Water St.
Danvers,  MA  01983
Applicant Contact SERGIO FINKIELSZTEIN
Correspondent
Marine Polymer Technologies
107 Water St.
Danvers,  MA  01983
Correspondent Contact SERGIO FINKIELSZTEIN
Classification Product Code
FRO  
Date Received07/15/2010
Decision Date 07/28/2010
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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