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510(k) K172537

Codman EDS 3 CSF External Drainage System, Codman EDS 3 CSF External Drainage System Collection Bag by Codman & Shurtleff, Inc. — Product Code JXG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 16, 2017
Date Received
August 22, 2017
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Shunt, Central Nervous System And Components
Device Class
Class II
Regulation Number
882.5550
Review Panel
NE
Submission Type

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