FDA 510(k) Application Details - K111584

Device Classification Name	Mesh, Surgical   More FDA Info for this Device
510(K) Number	K111584
Device Name	Mesh, Surgical
Applicant	XYLOS CORPORATION 838 TOWN CENTER DR. LANGHORNE, PA 19047 US Other 510(k) Applications for this Company
Contact	GONZALO C SERAFICA 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	06/07/2011
Decision Date	08/25/2011
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