FDA 510(k) Application Details - K040888

Device Classification Name	Dura Substitute   More FDA Info for this Device
510(K) Number	K040888
Device Name	Dura Substitute
Applicant	COLLAGEN MATRIX, INC. 509 COMMERCE ST. FRANKLIN LAKES,, NJ 07417 US Other 510(k) Applications for this Company
Contact	PEGGY HANSEN 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	04/05/2004
Decision Date	12/01/2004
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