FDA 510(k) Application Details - K122890

Device Classification Name	Plate, Bone   More FDA Info for this Device
510(K) Number	K122890
Device Name	Plate, Bone
Applicant	INION OY LAAKARINKATU 2 TAMPERE 33520 FI Other 510(k) Applications for this Company
Contact	KATI MARTTINEN 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	09/20/2012
Decision Date	01/29/2013
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