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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 K072834
Device Name SIBEL SA VASCULAR CLAMP
Applicant
SURGICAL INSTRUMENTS BELGIUM SA
220 RIVER RD.
CLAREMONT,  NH  03743 -5647
Applicant Contact WILLIAM F GREENROSE
Correspondent
SURGICAL INSTRUMENTS BELGIUM SA
220 RIVER RD.
CLAREMONT,  NH  03743 -5647
Correspondent Contact WILLIAM F GREENROSE
Regulation Number870.4450
Classification Product Code
DXC  
Date Received10/03/2007
Decision Date 01/09/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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