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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 K030963
Device Name TRUFILL DCS ORBIT DETACHABLE COIL AND TRUFILL DCS SYRINGE, ALSO KNOWN AS THE TRUFILL DCS ORBIT DETACHABLE COIL SYSTEM
Applicant
CORDIS NEUROVASCULAR, INC.
14000 N.W. 57TH CT.
MIAMI LAKES,  FL  33014
Applicant Contact ALINA CARABALLO
Correspondent
CORDIS NEUROVASCULAR, INC.
14000 N.W. 57TH CT.
MIAMI LAKES,  FL  33014
Correspondent Contact ALINA CARABALLO
Regulation Number882.5950
Classification Product Code
HCG  
Date Received03/27/2003
Decision Date 06/20/2003
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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