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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 K080967
Device Name TRUFILL DCS ORBIT DETACHABLE COIL AND TRUFILL DCS SYRINGE OR TRUFILL DCS SYRINGE II, ALSO KNOWN AS THE TRUFILL DCS ORBIT
Applicant
Cordis Neurovascular, Inc.
14201 N.W 60th Ave.
Miami Lakes,  FL  33014
Applicant Contact Amarilys Machado
Correspondent
Cordis Neurovascular, Inc.
14201 N.W 60th Ave.
Miami Lakes,  FL  33014
Correspondent Contact Amarilys Machado
Regulation Number882.5950
Classification Product Code
HCG  
Date Received04/04/2008
Decision Date 05/02/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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