FDA 510(k) Application Details - K141165

Device Classification Name	Plate, Bone   More FDA Info for this Device
510(K) Number	K141165
Device Name	Plate, Bone
Applicant	SYNTHES (USA) PRODUCTS LLC 1302 WRIGHTS LANE EAST WEST CHESTER, PA 19380 US Other 510(k) Applications for this Company
Contact	Damon Lees 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	05/06/2014
Decision Date	10/17/2014
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