FDA 510(k) Application Details - K052309

Device Classification Name	Dynamometer, Ac-Powered   More FDA Info for this Device
510(K) Number	K052309
Device Name	Dynamometer, Ac-Powered
Applicant	SAEHAN CORP. 340 SHADY GROVE ROAD FLINTVILLE, TN 37335 US Other 510(k) Applications for this Company
Contact	CHARLIE MACK 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	08/24/2005
Decision Date	09/27/2005
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