FDA 510(k) Application Details - K990637

Device Classification Name	Prosthesis, Condyle, Mandibular, Temporary   More FDA Info for this Device
510(K) Number	K990637
Device Name	Prosthesis, Condyle, Mandibular, Temporary
Applicant	SYNTHES (USA) 1690 RUSSELL RD. PAOLI, PA 19301 US Other 510(k) Applications for this Company
Contact	ANGELA SILVESTRI 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	02/26/1999
Decision Date	10/22/1999
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