510(k) K893491

MODEL M2-150/I-150/M2-150T/M3-150/M2-150,300-300 by Cuda Products Co. — Product Code FST

K893491 is an FDA 510(k) premarket notification submitted by Cuda Products Co. for the device "MODEL M2-150/I-150/M2-150T/M3-150/M2-150,300-300". The FDA issued a decision of Substantially Equivalent on June 22, 1989. 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.