510(k) K880198

GEMINI SURGICAL LIGHT by American Sterilizer Co. — Product Code FSS

K880198 is an FDA 510(k) premarket notification submitted by American Sterilizer Co. for the device "GEMINI SURGICAL LIGHT". The FDA issued a decision of Substantially Equivalent on February 10, 1988. The device falls under product code FSS (Light, Surgical, Floor Standing), a Class II device regulated under 21 CFR 878.4580. American Sterilizer Co. has at least 10 other 510(k) clearances on record.