FDA 510(k) Application Details - K080694

Device Classification Name	Plate, Bone   More FDA Info for this Device
510(K) Number	K080694
Device Name	Plate, Bone
Applicant	OSTEOMED L.P. 3885 ARAPAHO RD. ADDISON, TX 75001 US Other 510(k) Applications for this Company
Contact	PIEDAD PENA Other 510(k) Applications for this Contact
Regulation Number	872.4760   More FDA Info for this Regulation Number
Classification Product Code	JEY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/11/2008
Decision Date	05/15/2008
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