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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 K901628
Device Name APPLIED VASCULAR DEVICES 6MM TRACTION CLIP
Applicant
Applied Vascular Devices, Inc.
26051 Merit Cir., #104
Laguna Hills,  CA  92653
Applicant Contact ROBERT P COOPER
Correspondent
Applied Vascular Devices, Inc.
26051 Merit Cir., #104
Laguna Hills,  CA  92653
Correspondent Contact ROBERT P COOPER
Regulation Number870.4450
Classification Product Code
DXC  
Date Received04/09/1990
Decision Date 07/06/1990
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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