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510(k) K123560

VASCULAR OCCLUSION SYSTEM (TRUFILL PUSHABLE COILS), AND TRUFILL DCS ORBIT DETACHABLE COIL SYSEM by Codman & Shurtleff, Inc. — Product Code HCG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 25, 2013
Date Received
November 19, 2012
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Neurovascular Embolization
Device Class
Class II
Regulation Number
882.5950
Review Panel
NE
Submission Type

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