FDA 510(k) Application Details - K001789

Device Classification Name	More FDA Info for this Device
510(K) Number	K001789
Device Name	SEAMGUARD STAPLE LINE REINFORCEMENT MATERIAL
Applicant	W.L. GORE & ASSOCIATES,INC 3450 WEST KILTIE LN. FLAGSTAFF,, AZ 86002 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	06/13/2000
Decision Date	07/06/2000
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