FDA 510(k) Application Details - K101197

Device Classification Name	Mesh, Surgical, Polymeric   More FDA Info for this Device
510(K) Number	K101197
Device Name	Mesh, Surgical, Polymeric
Applicant	SOFRADIM PRODUCTION 60 MIDDLETOWN AVENUE NORTH HAVEN, CT 06473 US Other 510(k) Applications for this Company
Contact	SHARON ALEXANDER 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	04/28/2010
Decision Date	05/05/2010
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review