Cincinnati Sub-Zero Products, Inc. - December 14, 2009
Issue Date
Dec 14, 2009
Region
Central
Category
Device
$117.00
Address 1
12011 Mosteller Rd.
City
Cincinnati
State
OH
Zip/Postal Code
45241
Country
US
Inspection Range
Oct 15, 2009 - Dec 14, 2009
Pages
10
First Observation
Your firm has introduced or delivered for introduction into interstate commerce Blanketrol II, Norm-O-Temp, Hemotherm, and WarmAir 135 devices that have been significantly changed or modified in design and intended use without submitting a pre market notification to FDA, as required by 21 CFR 807.82(a)(3).
Investigator(s): Maribeth G. Grattan and Rosaanna M. Voccaro