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FDA 510(k) Application Details - K132850
Device Classification Name
Dura Substitute
More FDA Info for this Device
510(K) Number
K132850
Device Name
Dura Substitute
Applicant
RTI SURGICAL, INC.
11621 Research Cir
ALACHUA, FL 32615 US
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Contact
ESTHER CARBON
Other 510(k) Applications for this Contact
Regulation Number
882.5910
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Classification Product Code
GXQ
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More FDA Info for this Product Code
Date Received
09/11/2013
Decision Date
03/31/2014
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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