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FDA 510(k) Application Details - K043280
Device Classification Name
Methyl Methacrylate For Cranioplasty
More FDA Info for this Device
510(K) Number
K043280
Device Name
Methyl Methacrylate For Cranioplasty
Applicant
BIOMET, INC.
56 EAST BELL DR.
BOX 587
WARSAW, IN 46581-0587 US
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Contact
KACY ARNOLD
Other 510(k) Applications for this Contact
Regulation Number
882.5300
More FDA Info for this Regulation Number
Classification Product Code
GXP
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
11/26/2004
Decision Date
12/21/2004
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
NE - Neurology
Review Advisory Committee
NE - Neurology
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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