510(k) K896961

HALUX EXLITE MINOR SURGERY LIGHT by Jedmed Instrument Co. — Product Code GBC

K896961 is an FDA 510(k) premarket notification submitted by Jedmed Instrument Co. for the device "HALUX EXLITE MINOR SURGERY LIGHT". The FDA issued a decision of Substantially Equivalent on February 22, 1990. The device falls under product code GBC (Lamp, Surgical, Incandescent), a Class II device regulated under 21 CFR 878.4580. Jedmed Instrument Co. has at least 10 other 510(k) clearances on record.