FDA 510(k) Application Details - K071612

Device Classification Name	Plate, Bone   More FDA Info for this Device
510(K) Number	K071612
Device Name	Plate, Bone
Applicant	MEDARTIS AG 11234 EL CAMINO REAL, STE 200 SAN DIEGO, CA 92130 US Other 510(k) Applications for this Company
Contact	LINDA SCHULZ 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	06/13/2007
Decision Date	09/11/2007
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