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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 K972881
Device Name CES VASCULAR OCCLUSION SYSTEM
Applicant
CORDIS NEUROVASCULAR, INC.
14000 N.W. 57TH CT.
MIAMI LAKES,  FL  33014
Applicant Contact ELSA I CHI
Correspondent
CORDIS NEUROVASCULAR, INC.
14000 N.W. 57TH CT.
MIAMI LAKES,  FL  33014
Correspondent Contact ELSA I CHI
Regulation Number882.5950
Classification Product Code
HCG  
Date Received08/05/1997
Decision Date 06/04/1998
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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