FDA 510(k) Application Details - K070961

Device Classification Name	Mesh, Surgical, Polymeric   More FDA Info for this Device
510(K) Number	K070961
Device Name	Mesh, Surgical, Polymeric
Applicant	BIOMERIX CORPORATION 1700 ROCKVILLE PIKE SUITE 400 ROCKVILLE, MD 20852 US Other 510(k) Applications for this Company
Contact	CHRISTINA L KICHULA 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	04/05/2007
Decision Date	02/25/2008
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