FDA 510(k) Application Details - K083336

Device Classification Name	System, Thermal Regulating   More FDA Info for this Device
510(K) Number	K083336
Device Name	System, Thermal Regulating
Applicant	SMITHS MEDICAL ASD, INC. 160 WEYMOUTH ST. ROCKLAND, MA 02370 US Other 510(k) Applications for this Company
Contact	CHRISTINE LLOYD 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	11/12/2008
Decision Date	06/03/2009
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