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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 K040615
Device Name COMPRESSAR SUPERCOMFORT DISC AND STRONGARM SUPERCOMFORT SYSTEM
Applicant
ADVANCED VASCULAR DYNAMICS
2326 NW EVERETT ST.
portland,  OR  97210
Applicant Contact herbert j semler
Correspondent
ADVANCED VASCULAR DYNAMICS
2326 NW EVERETT ST.
portland,  OR  97210
Correspondent Contact herbert j semler
Regulation Number870.4450
Classification Product Code
DXC  
Date Received03/09/2004
Decision Date 06/01/2004
Decision substantially equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
summary summary
Type Special
Reviewed by Third Party No
Combination Product No
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