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510(k) K161090

Cranial PSI by Ossdsign AB — Product Code GXN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 19, 2017
Date Received
April 18, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Plate, Cranioplasty, Preformed, Non-Alterable
Device Class
Class II
Regulation Number
882.5330
Review Panel
NE
Submission Type

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