FDA 510(k) Application Details - K033092

Device Classification Name	Plate, Bone   More FDA Info for this Device
510(K) Number	K033092
Device Name	Plate, Bone
Applicant	ORTHO GNATHICS LLC 5001 BAUM BOULEVARD SUITE 799 PITTSBURGH, PA 15213 US Other 510(k) Applications for this Company
Contact	KENNETH J POLK 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	09/29/2003
Decision Date	04/21/2004
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	DE - Dental
Review Advisory Committee	DE - Dental
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review