FDA 510(k) Application Details - K110816

Device Classification Name	Mesh, Surgical, Polymeric   More FDA Info for this Device
510(K) Number	K110816
Device Name	Mesh, Surgical, Polymeric
Applicant	SOFRADIM PRODUCTION BIOSURGERY 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	03/24/2011
Decision Date	04/19/2011
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review