FDA 510(k) Application Details - K081538

Device Classification Name	Mesh, Surgical   More FDA Info for this Device
510(K) Number	K081538
Device Name	Mesh, Surgical
Applicant	RTI BIOLOGICS, INC. 11621 RESEARCH CIRCLE P.O. BOX 2650 ALACHUA, FL 32616-1627 US Other 510(k) Applications for this Company
Contact	TRAVIS AROLA 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	06/02/2008
Decision Date	06/19/2008
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review