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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 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
Correspondent Contact JAMES KETNER
Regulation Number882.5330
Classification Product Code
GXN  
Date Received12/08/2010
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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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