FDA 510(k) Application Details - K964354

Device Classification Name	Pack, Hot Or Cold, Water Circulating   More FDA Info for this Device
510(K) Number	K964354
Device Name	Pack, Hot Or Cold, Water Circulating
Applicant	ORMED GMBH 1000 BURNETTE AVE., SUITE 450 CONCORD, CA 94520 US Other 510(k) Applications for this Company
Contact	DAVID W SCHLERF 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	10/31/1996
Decision Date	08/29/1997
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