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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 K121818
Device Name OSTEOFAB PATIENT SPECIFIC CRANIAL DEVICE
Original Applicant
OXFORD PERFORMANCE MATERIALS
30 s satellite road
south windsor,  CT  06074
Original Contact leigh ayres
Regulation Number882.5330
Classification Product Code
GXN  
Date Received06/20/2012
Decision Date 02/07/2013
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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