510(k) K813474

MAXILL-AIR SINUS VENTILATION TUBE by Xomed, Inc. — Product Code KAM

K813474 is an FDA 510(k) premarket notification submitted by Xomed, Inc. for the device "MAXILL-AIR SINUS VENTILATION TUBE". The FDA issued a decision of Substantially Equivalent on January 12, 1982. The device falls under product code KAM (Cannula, Sinus), a Class I device regulated under 21 CFR 878.4800. Xomed, Inc. has at least 10 other 510(k) clearances on record.