510(k) K882449

CESIUM 137 SOURCE, MODEL CSM-40 by Cis-Us, Inc. — Product Code IWI

K882449 is an FDA 510(k) premarket notification submitted by Cis-Us, Inc. for the device "CESIUM 137 SOURCE, MODEL CSM-40". The FDA issued a decision of Substantially Equivalent on April 14, 1989. The device falls under product code IWI (Source, Isotope, Sealed, Gold, Titanium, Platinum), a Class II device regulated under 21 CFR 892.5730. Cis-Us, Inc. has at least 8 other 510(k) clearances on record.