FDA 510(k) Application Details - K024128

Device Classification Name	System, Thermal Regulating   More FDA Info for this Device
510(K) Number	K024128
Device Name	System, Thermal Regulating
Applicant	MTRE ADVANCED TECHNOLOGY LTD. 6052 WILMINGTON PIKE #225 CENTERVILLE, OH 45459 US Other 510(k) Applications for this Company
Contact	DOUGLAS RASH 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	12/16/2002
Decision Date	02/10/2003
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review