FDA 510(k) Application Details - K071341

Device Classification Name	System, Thermal Regulating   More FDA Info for this Device
510(K) Number	K071341
Device Name	System, Thermal Regulating
Applicant	MEDIVANCE, INC. 1172 CENTURY DR., SUITE 240 LOUISVILLE, CO 80027 US Other 510(k) Applications for this Company
Contact	LYNNE ARONSON 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	05/14/2007
Decision Date	08/03/2007
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