FDA 510(k) Application Details - K133398

Device Classification Name	External Mandibular Fixator And/Or Distractor   More FDA Info for this Device
510(K) Number	K133398
Device Name	External Mandibular Fixator And/Or Distractor
Applicant	Stryker 750 TRADE CENTRE WAY STE 200 PORTAGE, MI 49002 US Other 510(k) Applications for this Company
Contact	Manish Patel 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	11/06/2013
Decision Date	03/20/2014
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