510(k) K002828

XPS NITRO SYSTEM by Xomed, Inc. — Product Code ERL

K002828 is an FDA 510(k) premarket notification submitted by Xomed, Inc. for the device "XPS NITRO SYSTEM". The FDA issued a decision of Substantially Equivalent on October 17, 2000. The device falls under product code ERL (Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece), a Class II device regulated under 21 CFR 874.4250. Xomed, Inc. has at least 10 other 510(k) clearances on record.