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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 K082324
Device Name TRUFILL DCS SYRINGE
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 Received08/14/2008
Decision Date 09/12/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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