FDA 510(k) Application Details - K141686

Device Classification Name	System, Thermal Regulating   More FDA Info for this Device
510(K) Number	K141686
Device Name	System, Thermal Regulating
Applicant	SMITH MEDICAL ASD, INC. 1265 GREY FOX ROAD ST. PAUL, MN 55112 US Other 510(k) Applications for this Company
Contact	JIM JOHNSON 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	06/23/2014
Decision Date	10/28/2014
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