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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 K983483
FOIA Releasable 510(k) K983483
Device Name VASCULAR OCCLUSION SYSTEM
Applicant
Cordis Neurovascular, Inc.
14000 NW 57th Ct.
Miami Lakes,  FL  33014
Applicant Contact MARTINE D SCHNEIDER
Correspondent
Cordis Neurovascular, Inc.
14000 NW 57th Ct.
Miami Lakes,  FL  33014
Correspondent Contact MARTINE D SCHNEIDER
Regulation Number882.5950
Classification Product Code
HCG  
Date Received10/05/1998
Decision Date 03/24/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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