510(k) K901491

CUDA SURGICAL LIGHT by Cuda Products Co. — Product Code FST

K901491 is an FDA 510(k) premarket notification submitted by Cuda Products Co. for the device "CUDA SURGICAL LIGHT". The FDA issued a decision of Substantially Equivalent on June 18, 1990. The device falls under product code FST (Light, Surgical, Fiberoptic), a Class II device regulated under 21 CFR 878.4580. Cuda Products Co. has at least 10 other 510(k) clearances on record.