ORiGO System

Drill, Surgical, Ent (electric Or Pneumatic) Including Handpiece

Bien-Air Surgery SA

The following data is part of a premarket notification filed by Bien-air Surgery Sa with the FDA for Origo System.

Pre-market Notification Details

Device IDK221184
510k NumberK221184
Device Name:ORiGO System
ClassificationDrill, Surgical, Ent (electric Or Pneumatic) Including Handpiece
Applicant Bien-Air Surgery SA Rue De L'Ouest 2b Le Noirmont,  CH 2340
ContactJonas Guerdat
CorrespondentYulia Nikova
Ken Block Consulting, LLC 800 E. Campbell Rd. Suite 202 Richardson,  TX  75081
Product CodeERL  
Subsequent Product CodeEQJ
Subsequent Product CodeNLY
CFR Regulation Number874.4250 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-04-25
Decision Date2022-11-02

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