FDA 510(k) Application Details - K053022

Device Classification Name	Bone Grafting Material, Synthetic   More FDA Info for this Device
510(K) Number	K053022
Device Name	Bone Grafting Material, Synthetic
Applicant	SYNTHES (USA) 1302 WRIGHTS LANE EAST WEST CHESTER, PA 19380 US Other 510(k) Applications for this Company
Contact	SHERI L MUSGNUNG Other 510(k) Applications for this Contact
Regulation Number	872.3930   More FDA Info for this Regulation Number
Classification Product Code	LYC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/26/2005
Decision Date	01/23/2006
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	DE - Dental
Review Advisory Committee	DE - Dental
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review