CUSTOM CRANIOFACIAL IMPLANT (CCI)


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

Correspodent Contact nicholas breault
Regulation Number 882.5330
Classification Product Code
GXN  
Date Received 06/15/2012
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