FDA 510(k) Application Details - K061934

Device Classification Name	Mesh, Surgical, Polymeric   More FDA Info for this Device
510(K) Number	K061934
Device Name	Mesh, Surgical, Polymeric
Applicant	OSTEOGENICS, INC. 7781 LAKEVIEW DR. BURLINGTON, WI 53105-8119 US Other 510(k) Applications for this Company
Contact	MICHAEL DEUTSCH 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	07/07/2006
Decision Date	07/17/2007
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review