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FDA 510(k) Application Details - K152481
Device Classification Name
Dura Substitute
More FDA Info for this Device
510(K) Number
K152481
Device Name
Dura Substitute
Applicant
CODMAN & SHURTLEFF, INC.
325 PARAMOUNT DRIVE
RAYNHAM, MA 02767 US
Other 510(k) Applications for this Company
Contact
JENNIFER SIU
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
08/31/2015
Decision Date
10/30/2015
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
NE - Neurology
Review Advisory Committee
NE - Neurology
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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