FDA 510(k) Application Details - K031701

Device Classification Name	Prosthesis, Condyle, Mandibular, Temporary   More FDA Info for this Device
510(K) Number	K031701
Device Name	Prosthesis, Condyle, Mandibular, Temporary
Applicant	OSTEOMED L.P. 3885 ARAPAHO RD. ADDISON, TX 75001 US Other 510(k) Applications for this Company
Contact	DAWN T HOLDEMAN 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	06/02/2003
Decision Date	07/08/2004
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