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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 K071962
Device Name VASCULAR OCCLUSION SYSTEM (TRUFILL PUSHABLE COILS AND TRUPUSH COIL PUSHER)
Applicant
Cordis Neurovascular, Inc.
14000 NW 57th Ct.
Miami Lakes,  FL  33014
Applicant Contact Amarilys Machado
Correspondent
Cordis Neurovascular, Inc.
14000 NW 57th Ct.
Miami Lakes,  FL  33014
Correspondent Contact Amarilys Machado
Regulation Number882.5950
Classification Product Code
HCG  
Date Received07/16/2007
Decision Date 09/26/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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