510(k) K983277

LIGHTSOURCE OR ILLUMINATOR MODEL I-100 by Cuda Products Co. — Product Code HBI

K983277 is an FDA 510(k) premarket notification submitted by Cuda Products Co. for the device "LIGHTSOURCE OR ILLUMINATOR MODEL I-100". The FDA issued a decision of Substantially Equivalent on December 16, 1998. The device falls under product code HBI (Illuminator, Fiberoptic, Surgical Field), a Class II device regulated under 21 CFR 878.4580. Cuda Products Co. has at least 10 other 510(k) clearances on record.