Simplifying Global Compliance
Cincinnati Sub-Zero Products, Inc. - December 14, 2009
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).
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