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510(k) K103582

KELYNIAM CUSTOM SKULL IMPLANT (CSI) by Kelyniam Global, Inc. — Product Code GXN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 14, 2011
Date Received
December 8, 2010
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

Other clearances by Kelyniam Global, Inc.

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  • K121755 — CUSTOM CRANIOFACIAL IMPLANT (CCI) (September 25, 2012)

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