FDA 510(k) Application Details - K082951

Device Classification Name	Bath, Hydro-Massage   More FDA Info for this Device
510(K) Number	K082951
Device Name	Bath, Hydro-Massage
Applicant	ARJO HOSPITAL EQUIPMENT AB 50 NORTH GARY AVENUE, SUITE A ROSELLE, IL 60172-1684 US Other 510(k) Applications for this Company
Contact	TRACI GIOVENCO Other 510(k) Applications for this Contact
Regulation Number	890.5100   More FDA Info for this Regulation Number
Classification Product Code	ILJ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/03/2008
Decision Date	04/08/2009
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	PM - Physical Medicine
Review Advisory Committee	PM - Physical Medicine
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review