FDA 510(k) Application Details - K070112

Device Classification Name	System, Thermal Regulating   More FDA Info for this Device
510(K) Number	K070112
Device Name	System, Thermal Regulating
Applicant	MEDCOOL INC 5 TIMBER LANE NORTH READING, MA 01864 US Other 510(k) Applications for this Company
Contact	MAUREEN O'CONNELL 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	01/11/2007
Decision Date	07/13/2007
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