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510(k) K170368

Sterile NS System by Jeil Medical Corporation — Product Code GWO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 11, 2017
Date Received
February 6, 2017
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Plate, Cranioplasty, Preformed, Alterable
Device Class
Class II
Regulation Number
882.5320
Review Panel
NE
Submission Type

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