FDA 510(k) Application Details - K063435

Device Classification Name	Mesh, Surgical, Polymeric   More FDA Info for this Device
510(K) Number	K063435
Device Name	Mesh, Surgical, Polymeric
Applicant	W. L. GORE & ASSOCIATES, INC. 3450 WEST KILTIE LN. FLAGSTAFF, AZ 86001 US Other 510(k) Applications for this Company
Contact	Michael Ivey 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	11/13/2006
Decision Date	11/28/2006
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review