FDA 510(k) Application Details - K963731

Device Classification Name	System, Thermal Regulating   More FDA Info for this Device
510(K) Number	K963731
Device Name	System, Thermal Regulating
Applicant	ENTHERMICS MEDICAL SYSTEMS, INC. P.O. BOX 17627 SALT LAKE CITY, UT 84117 US Other 510(k) Applications for this Company
Contact	JAMES DIRKSEN Other 510(k) Applications for this Contact
Regulation Number	870.5900   More FDA Info for this Regulation Number
Classification Product Code	DWJ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/17/1996
Decision Date	04/22/1997
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review