510(k) K042395

OUTPATIENT III MINOR SURGERY LIGHT by Burton Medical Products Corp. — Product Code FSY

K042395 is an FDA 510(k) premarket notification submitted by Burton Medical Products Corp. for the device "OUTPATIENT III MINOR SURGERY LIGHT". The FDA issued a decision of Substantially Equivalent on December 1, 2004. The device falls under product code FSY (Light, Surgical, Ceiling Mounted), a Class II device regulated under 21 CFR 878.4580. Burton Medical Products Corp. has at least 10 other 510(k) clearances on record.