FDA 510(k) Application Details - K083266

Device Classification Name	Mesh, Surgical, Polymeric   More FDA Info for this Device
510(K) Number	K083266
Device Name	Mesh, Surgical, Polymeric
Applicant	W.L. GORE & ASSOCIATES,INC 301 AIRPORT RD. ELKTON, MD 21921 US Other 510(k) Applications for this Company
Contact	BARBARA L SMITH Other 510(k) Applications for this Contact
Regulation Number	878.3300   More FDA Info for this Regulation Number
Classification Product Code	FTL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/05/2008
Decision Date	03/27/2009
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