FDA 510(k) Application Details - K110104

Device Classification Name	System, Thermal Regulating   More FDA Info for this Device
510(K) Number	K110104
Device Name	System, Thermal Regulating
Applicant	CINCINNATI SUB-ZERO PRODUCTS, INC. 12011 MOSTELLER RD. CINCINNATI, OH 45241 US Other 510(k) Applications for this Company
Contact	STEVEN J BERKE 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	01/13/2011
Decision Date	02/04/2011
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