FDA 510(k) Application Details - K081747

Device Classification Name	Prosthesis, Condyle, Mandibular, Temporary   More FDA Info for this Device
510(K) Number	K081747
Device Name	Prosthesis, Condyle, Mandibular, Temporary
Applicant	SYNTHES (USA) 1301 GOSHEN PKWY WEST CHESTER, PA 19380 US Other 510(k) Applications for this Company
Contact	ANDREA M TASKER Other 510(k) Applications for this Contact
Regulation Number	872.3960   More FDA Info for this Regulation Number
Classification Product Code	NEI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/19/2008
Decision Date	09/05/2008
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