FDA 510(k) Application Details - K083008

Device Classification Name	Pack, Hot Or Cold, Water Circulating   More FDA Info for this Device
510(K) Number	K083008
Device Name	Pack, Hot Or Cold, Water Circulating
Applicant	ELBIO CO., LTD 845 ARONSON LAKE COURT ROSWELL, GA 30075 US Other 510(k) Applications for this Company
Contact	JAY MANSOUR Other 510(k) Applications for this Contact
Regulation Number	890.5720   More FDA Info for this Regulation Number
Classification Product Code	ILO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/08/2008
Decision Date	06/10/2009
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	PM - Physical Medicine
Review Advisory Committee	PM - Physical Medicine
Statement / Summary / Purged Status	Summary
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review