FDA 510(k) Application Details - K050378

Device Classification Name	External Mandibular Fixator And/Or Distractor   More FDA Info for this Device
510(K) Number	K050378
Device Name	External Mandibular Fixator And/Or Distractor
Applicant	SYNTHES (USA) 1690 RUSSELL RD. PAOLI, PA 19301 US Other 510(k) Applications for this Company
Contact	SHERI L MUSGNUNG 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	02/15/2005
Decision Date	03/15/2005
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