510(k) K981962

CUDA PRODUCTS CORP. MODEL M300 (M-300) LIGHTSOURCE by Cuda Products Co. — Product Code FSS

K981962 is an FDA 510(k) premarket notification submitted by Cuda Products Co. for the device "CUDA PRODUCTS CORP. MODEL M300 (M-300) LIGHTSOURCE". The FDA issued a decision of Substantially Equivalent on August 18, 1998. The device falls under product code FSS (Light, Surgical, Floor Standing), a Class II device regulated under 21 CFR 878.4580. Cuda Products Co. has at least 10 other 510(k) clearances on record.