510(k) K980166

LIGHTSOURCE OR ILLUMINATOR by Cuda Products Co. — Product Code HET

K980166 is an FDA 510(k) premarket notification submitted by Cuda Products Co. for the device "LIGHTSOURCE OR ILLUMINATOR". The FDA issued a decision of Substantially Equivalent on April 1, 1998. The device falls under product code HET (Laparoscope, Gynecologic (And Accessories)), a Class II device regulated under 21 CFR 884.1720. Cuda Products Co. has at least 10 other 510(k) clearances on record.