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FDA 510(k) Application Details - K051093
Device Classification Name
Methyl Methacrylate For Cranioplasty
More FDA Info for this Device
510(K) Number
K051093
Device Name
Methyl Methacrylate For Cranioplasty
Applicant
OSTEOPORE, INC.
958 KRISTIN RIDGE WAY
MILPITAS, CA 95035 US
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Contact
ALEXANDER YEO
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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
04/28/2005
Decision Date
03/17/2006
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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