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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
Contact nicholas breault
Regulation Number882.5330
Classification Product Code
GXN  
Date Received06/15/2012
Decision Date 09/25/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Neurology
Review Advisory Committee Neurology
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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