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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 K901565
Device Name ATRAUMAX SURGICAL CLAMP MODEL FOG-5048, 75MM SIDE
Applicant
APPLIED VASCULAR DEVICES, INC.
26051 MERIT CIRCLE, #104
LAGUNA HILLS,  CA  92653
Applicant Contact ROBERT P COOPER
Correspondent
APPLIED VASCULAR DEVICES, INC.
26051 MERIT CIRCLE, #104
LAGUNA HILLS,  CA  92653
Correspondent Contact ROBERT P COOPER
Regulation Number870.4450
Classification Product Code
DXC  
Date Received04/03/1990
Decision Date 06/12/1990
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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