FDA 510(k) Application Details - K130547

Device Classification Name	Mesh, Surgical   More FDA Info for this Device
510(K) Number	K130547
Device Name	Mesh, Surgical
Applicant	MESYNTHE LTD 11440 W. BERNARDO CT SUITE 300 SAN DIEGO, CA 92127 US Other 510(k) Applications for this Company
Contact	RONALD WARREN 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	03/04/2013
Decision Date	05/31/2013
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