FDA 510(k) Application Details - K083039

Device Classification Name	Mesh, Surgical   More FDA Info for this Device
510(K) Number	K083039
Device Name	Mesh, Surgical
Applicant	SYNOVIS SURGICAL INNOVATIONS 2575 UNIVERSITY AVE. WEST ST. PAUL, MN 55114-1024 US Other 510(k) Applications for this Company
Contact	JODI JORGENSON Other 510(k) Applications for this Contact
Regulation Number	878.3300   More FDA Info for this Regulation Number
Classification Product Code	FTM Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/14/2008
Decision Date	11/26/2008
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