510(k) K132297

EM SINUS DILATION SYSTEM by Medtronic Xomed, Inc. — Product Code LRC

K132297 is an FDA 510(k) premarket notification submitted by Medtronic Xomed, Inc. for the device "EM SINUS DILATION SYSTEM". The FDA issued a decision of Substantially Equivalent on November 5, 2013. The device falls under product code LRC (Instrument, Ent Manual Surgical), a Class I device regulated under 21 CFR 874.4420. Medtronic Xomed, Inc. has at least 10 other 510(k) clearances on record.