FDA 510(k) Application Details - K955326

Device Classification Name	Pack, Hot Or Cold, Water Circulating   More FDA Info for this Device
510(K) Number	K955326
Device Name	Pack, Hot Or Cold, Water Circulating
Applicant	BURKE NEUTECH, INC. 1765 COMMERCE AVE. NORTH ST. PETERSBURG, FL 33716 US Other 510(k) Applications for this Company
Contact	ROBERT E BURKE 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	11/20/1995
Decision Date	04/10/1996
Decision	SN - Substantially Equivalent for Some Indications
Classification Advisory Committee	PM - Physical Medicine
Review Advisory Committee	PM - Physical Medicine
Statement / Summary / Purged Status
Type	Traditional
Reviewed By Third Party	N
Expedited Review