FDA 510(k) Application Details - K094056

Device Classification Name	System, Thermal Regulating   More FDA Info for this Device
510(K) Number	K094056
Device Name	System, Thermal Regulating
Applicant	AUGUSTINE BIOMEDICAL & DESIGN, LLC 6581 CITY WEST PARKWAY EDEN PRAIRIE, MN 55344 US Other 510(k) Applications for this Company
Contact	JAMES ECKLEIN 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	12/31/2009
Decision Date	06/03/2010
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	Y
Expedited Review