510(k) K844087

XANAR MODEL XSE-300 SMOKE EVACULATER by Xanar, Inc. — Product Code FYD

K844087 is an FDA 510(k) premarket notification submitted by Xanar, Inc. for the device "XANAR MODEL XSE-300 SMOKE EVACULATER". The FDA issued a decision of Substantially Equivalent on February 27, 1985. The device falls under product code FYD (Apparatus, Exhaust, Surgical), a Class II device regulated under 21 CFR 878.5070. Xanar, Inc. has at least 10 other 510(k) clearances on record.