FDA 510(k) Application Details - K083898

Device Classification Name	Mesh, Surgical   More FDA Info for this Device
510(K) Number	K083898
Device Name	Mesh, Surgical
Applicant	TEI BIOSCIENCES INC. 7 ELKINS ST. BOSTON, MA 02127 US Other 510(k) Applications for this Company
Contact	KENNETH JAMES 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	12/29/2008
Decision Date	02/04/2009
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review