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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Plate, Cranioplasty, Preformed, Non-Alterable
510(k) Number K121755
Device Name CUSTOM CRANIOFACIAL IMPLANT (CCI)
Applicant
KELYNIAM GLOBAL, INC.
97 River Rd
STE A
Canton,  CT  06019
Applicant Contact NICHOLAS BREAULT
Correspondent
KELYNIAM GLOBAL, INC.
97 River Rd
STE A
Canton,  CT  06019
Correspondent Contact NICHOLAS BREAULT
Regulation Number882.5330
Classification Product Code
GXN  
Date Received06/15/2012
Decision Date 09/25/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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