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510(k) K171862

GALAXY G3 Mini Microcoil Delivery System by Codman & Shurtleff, Inc. — Product Code HCG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 25, 2017
Date Received
June 22, 2017
Clearance Type
Traditional
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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  • K162437 — Codman EDS3 CSF External Drainage System (October 28, 2016)
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