FDA 510(k) Application Details - K082079

Device Classification Name	Scaffold, Partial Medial Meniscal Defects Extending Into The Red/White Zone, Resorbable Bovine Collagen   More FDA Info for this Device
510(K) Number	K082079
Device Name	Scaffold, Partial Medial Meniscal Defects Extending Into The Red/White Zone, Resorbable Bovine Collagen
Applicant	REGEN BIOLOGICS, INC. 411 HACKENSACK AVENUE HACKENSACK, NJ 07601 US Other 510(k) Applications for this Company
Contact	JOHN DICHIARA Other 510(k) Applications for this Contact
Regulation Number	878.3300   More FDA Info for this Regulation Number
Classification Product Code	OLC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/23/2008
Decision Date	12/18/2008
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review