510(k) K893813

FLOOR STANDING, OPERATING AND EXAMINING LIGHT by Astralite Corp. — Product Code FSS

K893813 is an FDA 510(k) premarket notification submitted by Astralite Corp. for the device "FLOOR STANDING, OPERATING AND EXAMINING LIGHT". The FDA issued a decision of Substantially Equivalent on July 14, 1989. The device falls under product code FSS (Light, Surgical, Floor Standing), a Class II device regulated under 21 CFR 878.4580. Astralite Corp. has at least 1 other 510(k) clearance on record.