FDA 510(k) Application Details - K980363

Device Classification Name	Dynamometer, Ac-Powered   More FDA Info for this Device
510(K) Number	K980363
Device Name	Dynamometer, Ac-Powered
Applicant	OROFACIAL DYNAMICS PO BOX 1082 ALAMO, CA 94507 US Other 510(k) Applications for this Company
Contact	RONALD E TURA Other 510(k) Applications for this Contact
Regulation Number	888.1240   More FDA Info for this Regulation Number
Classification Product Code	LBB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/29/1998
Decision Date	04/16/1998
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OR - Orthopedic
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review