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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Clamp, Carotid Artery
510(k) Number K811821
Device Name CAROTID ARTERY CLAMP & TOOLS
Applicant
NEW ENGLAND SURGICAL INSTRUMENT CORP.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
NEW ENGLAND SURGICAL INSTRUMENT CORP.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number882.5175
Classification Product Code
HCE  
Date Received06/29/1981
Decision Date 09/24/1981
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
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