510(k) K083720

OSSEODUO, SHAVER HANDPIECE S80 AND S120, MICROMOTOR 80K by Bien-Air Surgery SA — Product Code ERL

K083720 is an FDA 510(k) premarket notification submitted by Bien-Air Surgery SA for the device "OSSEODUO, SHAVER HANDPIECE S80 AND S120, MICROMOTOR 80K". The FDA issued a decision of Substantially Equivalent on March 20, 2009. 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. Bien-Air Surgery SA has at least 4 other 510(k) clearances on record.