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510(k) K121755

CUSTOM CRANIOFACIAL IMPLANT (CCI) by Kelyniam Global, Inc. — Product Code GXN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 25, 2012
Date Received
June 15, 2012
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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  • K103582 — KELYNIAM CUSTOM SKULL IMPLANT (CSI) (April 14, 2011)

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