FDA 510(k) Application Details - K080458

Device Classification Name	External Mandibular Fixator And/Or Distractor   More FDA Info for this Device
510(K) Number	K080458
Device Name	External Mandibular Fixator And/Or Distractor
Applicant	MIS - IMPLANT TECHNOLOGIES LTD. POB 110 SHLOMI INDUSTRIAL ZONE SHLOMI 22832 IL Other 510(k) Applications for this Company
Contact	IMAN KHORSHID 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	02/20/2008
Decision Date	12/17/2008
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