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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bandage, Liquid
510(k) Number K002550
Device Name RDH BANDAGE
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
Regulation Number880.5090
Classification Product Code
KMF  
Date Received08/17/2000
Decision Date 12/20/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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