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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 K121102
Device Name OSTEOSYMBIONICS PEEK CRANIAL IMPLANT
Applicant
OSTEOSYMBIONICS, LLC
P.O. BOX 560
STILLWATER,  MN  55082
Applicant Contact ELAINE DUNCAN
Correspondent
OSTEOSYMBIONICS, LLC
P.O. BOX 560
STILLWATER,  MN  55082
Correspondent Contact ELAINE DUNCAN
Regulation Number882.5330
Classification Product Code
GXN  
Date Received04/11/2012
Decision Date 08/08/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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