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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 K123560
Device Name VASCULAR OCCLUSION SYSTEM (TRUFILL PUSHABLE COILS), AND TRUFILL DCS ORBIT DETACHABLE COIL SYSEM
Applicant
Codman & Shurtleff, Inc.
325 Paramount Dr.
Raynham,  MA  02767 -0350
Applicant Contact RICHARD KIMURA
Correspondent
Codman & Shurtleff, Inc.
325 Paramount Dr.
Raynham,  MA  02767 -0350
Correspondent Contact RICHARD KIMURA
Regulation Number882.5950
Classification Product Code
HCG  
Date Received11/19/2012
Decision Date 01/25/2013
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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