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510(k) K141644

INNOVASIS CRANIAL SYSTEM by Innovasis, Inc. — Product Code GWO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 7, 2014
Date Received
June 19, 2014
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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