Cleared Traditional

OSSEODUO, SHAVER HANDPIECE S80 AND S120, MICROMOTOR 80K

K083720 · Bien-Air Surgery SA · Ear, Nose, Throat

Mar 2009

Decision

95d

Days

Class 2

Risk

About This 510(k) Submission

K083720 is an FDA 510(k) clearance for the OSSEODUO, SHAVER HANDPIECE S80 AND S120, MICROMOTOR 80K, a Drill, Surgical, Ent (electric Or Pneumatic) Including Handpiece (Class II — Special Controls, product code ERL), submitted by Bien-Air Surgery SA (Le Noirmont, CH). The FDA issued a Cleared decision on March 20, 2009, 95 days after receiving the submission on December 15, 2008. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.4250.

Submission Details

510(k) Number	K083720 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 15, 2008
Decision Date	March 20, 2009
Days to Decision	95 days
Submission Type	Traditional
Review Panel	Ear, Nose, Throat (EN)
Summary	Summary PDF

Device Classification

Product Code	ERL — Drill, Surgical, Ent (electric Or Pneumatic) Including Handpiece
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 874.4250