FDA 510(k) Application Details - K972047

Device Classification Name	External Mandibular Fixator And/Or Distractor   More FDA Info for this Device
510(K) Number	K972047
Device Name	External Mandibular Fixator And/Or Distractor
Applicant	KLS-MARTIN L.P. 40178 U.S. 19 NORTH TARPON SPRINGS, FL 34689 US Other 510(k) Applications for this Company
Contact	ED RANSOM 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	06/02/1997
Decision Date	06/24/1997
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	DE - Dental
Review Advisory Committee	DE - Dental
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review