510(k) K822240

ETHYLENE OXIDE STERILIZ. PARAMETRIC REL. by American Mcgaw — Product Code KFX

K822240 is an FDA 510(k) premarket notification submitted by American Mcgaw for the device "ETHYLENE OXIDE STERILIZ. PARAMETRIC REL.". The FDA issued a decision of Substantially Equivalent on December 30, 1982. The device falls under product code KFX (Assembly, Thigh/Knee/Shank/Ankle/Foot, External), a Class II device regulated under 21 CFR 890.3500. American Mcgaw has at least 10 other 510(k) clearances on record.