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