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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 K881158
Device Name VASCULAR CLAMP
Applicant
T. Korossurgical Instruments Corp.
610 Flinn Ave.
Moorepark,  CA  93021
Applicant Contact TIBOR KOROS
Correspondent
T. Korossurgical Instruments Corp.
610 Flinn Ave.
Moorepark,  CA  93021
Correspondent Contact TIBOR KOROS
Regulation Number870.4450
Classification Product Code
DXC  
Date Received03/18/1988
Decision Date 06/20/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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