FDA 510(k) Application Details - K101519

Device Classification Name	Mesh, Surgical, Polymeric   More FDA Info for this Device
510(K) Number	K101519
Device Name	Mesh, Surgical, Polymeric
Applicant	SOFRADIM PRODUCTION 15 CROSBY DRIVE BEDFORD, MA 01730 US Other 510(k) Applications for this Company
Contact	JAMES MCMAHON Other 510(k) Applications for this Contact
Regulation Number	878.3300   More FDA Info for this Regulation Number
Classification Product Code	FTL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/02/2010
Decision Date	11/05/2010
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