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FDA 510(k) Application Details - K042414
Device Classification Name
Methyl Methacrylate For Cranioplasty
More FDA Info for this Device
510(K) Number
K042414
Device Name
Methyl Methacrylate For Cranioplasty
Applicant
TECRES
ONE DEMOCRACY PLAZA
6701 DEMOCRACT BLVD. STE. 700
BETHESDA, MD 20817 US
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Contact
CHRISTINE BRAUER
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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
09/07/2004
Decision Date
12/29/2004
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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