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FDA 510(k) Application Details - K102018
Device Classification Name
Methyl Methacrylate For Cranioplasty
More FDA Info for this Device
510(K) Number
K102018
Device Name
Methyl Methacrylate For Cranioplasty
Applicant
SYNTHES USA PRODUCTS LLC
1230 WILSON DRIVE
WEST CHESTER, PA 19380 US
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Contact
JEFFREY L DOW
Other 510(k) Applications for this Contact
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
07/19/2010
Decision Date
09/23/2010
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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