FDA 510(k) Application Details - K112457

Device Classification Name	Plate, Bone   More FDA Info for this Device
510(K) Number	K112457
Device Name	Plate, Bone
Applicant	ARKIN CONSULTING GROUP 1733 CANTON LANE MARIETTA, GA 30062-2679 US Other 510(k) Applications for this Company
Contact	PAUL SUMNER 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	08/26/2011
Decision Date	05/18/2012
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	DE - Dental
Review Advisory Committee	DE - Dental
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review