FDA 510(k) Application Details - K073675

Device Classification Name	Pack, Hot Or Cold, Water Circulating   More FDA Info for this Device
510(K) Number	K073675
Device Name	Pack, Hot Or Cold, Water Circulating
Applicant	GAYMAR INDUSTRIES, INC. 140 PEARL STREET, SUITE 100 BUFFALO, NY 14202 US Other 510(k) Applications for this Company
Contact	BETHANY J GILBERT 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	12/28/2007
Decision Date	05/08/2008
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	PM - Physical Medicine
Review Advisory Committee	PM - Physical Medicine
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review