FDA 510(k) Application Details - K143285

Device Classification Name	External Mandibular Fixator And/Or Distractor   More FDA Info for this Device
510(K) Number	K143285
Device Name	External Mandibular Fixator And/Or Distractor
Applicant	Synthes USA Products, LLC 1302 Wrights Lane West Chester, PA 19380 US Other 510(k) Applications for this Company
Contact	Susan Lewandowski Other 510(k) Applications for this Contact
Regulation Number	872.4760   More FDA Info for this Regulation Number
Classification Product Code	MQN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/17/2014
Decision Date	05/28/2015
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