FDA 510(k) Application Details - K071629

Device Classification Name	Mesh, Surgical, Polymeric   More FDA Info for this Device
510(K) Number	K071629
Device Name	Mesh, Surgical, Polymeric
Applicant	SOFRADIM PRODUCTION HEALTHCARE GROUP 150 GLOVER AVE. NORWALK, CT 06856 US Other 510(k) Applications for this Company
Contact	RENEE BORGESANO 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	06/14/2007
Decision Date	07/10/2007
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