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FDA 510(k) Application Details - K161278
Device Classification Name
Dura Substitute
More FDA Info for this Device
510(K) Number
K161278
Device Name
Dura Substitute
Applicant
ACERA SURGICAL, INC.
10880 BAUR BLVD.
ST. LOUIS, MO 63132 US
Other 510(k) Applications for this Company
Contact
Matthew MacEwan
Other 510(k) Applications for this Contact
Regulation Number
882.5910
More FDA Info for this Regulation Number
Classification Product Code
GXQ
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
05/06/2016
Decision Date
08/08/2016
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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