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FDA 510(k) Application Details - K953339
Device Classification Name
Methyl Methacrylate For Cranioplasty
More FDA Info for this Device
510(K) Number
K953339
Device Name
Methyl Methacrylate For Cranioplasty
Applicant
OSTEOGENICS, INC.
250 EAST ARAPAHO RD.
RICHARDSON, TX 75081 US
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Contact
MARY BIGGERS
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Regulation Number
882.5300
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Classification Product Code
GXP
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More FDA Info for this Product Code
Date Received
07/17/1995
Decision Date
06/27/1996
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
NE - Neurology
Review Advisory Committee
NE - Neurology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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