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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, alterable
510(k) Number K111176
Device Name OSTEOMED LOW PROFILE NEURO FIXATION SYSTEM
Applicant
OSTEOMED L.P.
3885 ARAPAHO RD.
ADDISON,  TX  75001
Applicant Contact PIEDAD PENA
Correspondent
OSTEOMED L.P.
3885 ARAPAHO RD.
ADDISON,  TX  75001
Correspondent Contact PIEDAD PENA
Regulation Number882.5320
Classification Product Code
GWO  
Subsequent Product Code
GXR  
Date Received04/27/2011
Decision Date 08/15/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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