FDA 510(k) Applications Submitted by BIEN-AIR SURGERY SA

FDA 510(k) Number Submission Date Device Name Applicant
K173066 09/29/2017 OSSEODUO Shaver and Drill System Bien-Air Surgery SA
K083720 12/15/2008 OSSEODUO, SHAVER HANDPIECE S80 AND S120, MICROMOTOR 80K BIEN-AIR SURGERY SA
K221184 04/25/2022 ORiGO System Bien-Air Surgery SA
K213697 11/23/2021 ORiGO System Bien-Air Surgery SA
K143492 12/08/2014 OSSEOSTAP Microdrill System (control unit and handpiece), OSSEOSTAP control unit (foot pedal), OSSEOSTAP handpiece Bien-Air Surgery SA


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