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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Clamp, Vascular
510(k) Number K053300
Device Name SYVEKEXCEL
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 Number870.4450
Classification Product Code
DXC  
Date Received11/25/2005
Decision Date 03/28/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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