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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name device, neurovascular embolization
510(k) Number K964367
Device Name CES VASCULAR OCCLUSION SYSTEM
Applicant
CORDIS NEUROVASCULAR, INC.
14740 N.W. 60TH AVE.
MIAMI LAKES,  FL  33014
Applicant Contact ELSA I CHI
Correspondent
CORDIS NEUROVASCULAR, INC.
14740 N.W. 60TH AVE.
MIAMI LAKES,  FL  33014
Correspondent Contact ELSA I CHI
Regulation Number882.5950
Classification Product Code
HCG  
Date Received11/01/1996
Decision Date 01/30/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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