FDA 510(k) Application Details - K120141

Device Classification Name	Filler, Bone Void, Calcium Compound   More FDA Info for this Device
510(K) Number	K120141
Device Name	Filler, Bone Void, Calcium Compound
Applicant	KENSEY NASH CORORATION 735 PENNSYLVANIA DRIVE EXTON, PA 19464 US Other 510(k) Applications for this Company
Contact	Susan Pileggi Other 510(k) Applications for this Contact
Regulation Number	888.3045   More FDA Info for this Regulation Number
Classification Product Code	MQV Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/18/2012
Decision Date	05/04/2012
Decision	SESU - SE - WITH LIMITATIONS
Classification Advisory Committee	OR - Orthopedic
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review