KELYNIAM CUSTOM SKULL IMPLANT (CSI)


Device Classification Name

plate, cranioplasty, preformed, non-alterable

510(k) Number K103582
Device Name KELYNIAM CUSTOM SKULL IMPLANT (CSI)
Applicant
KELYNIAM GLOBAL, INC
200 myrtle street
2nd floor
new britain, 
CT 
06053

Applicant Contact james ketner
Correspondent
KELYNIAM GLOBAL, INC
200 myrtle street
2nd floor
new britain, 
CT 
06053

Correspodent Contact james ketner
Regulation Number 882.5330
Classification Product Code
GXN  
Date Received 12/08/2010
Decision Date 04/14/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Neurology

510k Review Panel

Neurology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No