510(k) K012456

SODEM HIGH SPEED SYSTEM (ELECTRIC) (EAR, NOSE, AND THROAT) by Sodemsystems — Product Code ERL

K012456 is an FDA 510(k) premarket notification submitted by Sodemsystems for the device "SODEM HIGH SPEED SYSTEM (ELECTRIC) (EAR, NOSE, AND THROAT)". The FDA issued a decision of Substantially Equivalent on September 21, 2001. 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. Sodemsystems has at least 7 other 510(k) clearances on record.