FDA 510(k) Application Details - K955364

Device Classification Name	More FDA Info for this Device
510(K) Number	K955364
Device Name	SEAMGUARD STAPLE LINE REINFORCEMENT MATERIAL
Applicant	W.L. GORE & ASSOCIATES,INC 3750 WEST KILTIE LN. P. O. BOX 500 FLAGSTAFF, AZ 86002-0500 US Other 510(k) Applications for this Company
Contact	R. LARRY PRATT Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OXD Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/22/1995
Decision Date	02/01/1996
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review