FDA 510(k) Application Details - K980548

Device Classification Name	Dura Substitute   More FDA Info for this Device
510(K) Number	K980548
Device Name	Dura Substitute
Applicant	BRIDGER BIOMED, INC. 2430 NORTH 7TH AVE., SUITE 4 BOZEMAN, MT 59715 US Other 510(k) Applications for this Company
Contact	BRUCE G RUEFER 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	02/12/1998
Decision Date	05/13/1998
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