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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 K014041
Device Name TRUFILL DCS DETACHABLE COIL AND FRUFILL DCS SYRINGE, ALSO KNOWN AS THE TRUFILL DCS DETACHABLE COIL SYSTEM
Applicant
CORDIS NEUROVASCULAR
14000 N.W. 57TH COURT
MIAMI LAKES,  FL  33014
Applicant Contact ALINA CARABALLO
Correspondent
CORDIS NEUROVASCULAR
14000 N.W. 57TH COURT
MIAMI LAKES,  FL  33014
Correspondent Contact ALINA CARABALLO
Regulation Number882.5950
Classification Product Code
HCG  
Subsequent Product Code
KRD  
Date Received12/07/2001
Decision Date 03/07/2002
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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