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FDA 510(k) Application Details - K122791
Device Classification Name
Dura Substitute
More FDA Info for this Device
510(K) Number
K122791
Device Name
Dura Substitute
Applicant
AESCULAP, INC.
3773 Corporate Parkway
Center Valley, PA 18034 US
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Contact
DENISE ADAMS
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
09/12/2012
Decision Date
06/04/2013
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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