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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece
510(k) Number K221184
Device Name ORiGO System
Applicant
Bien-Air Surgery SA
Rue de l'Ouest 2b
Le Noirmont,  CH 2340
Applicant Contact Jonas Guerdat
Correspondent
Ken Block Consulting, LLC
800 E. Campbell Rd.
Suite 202
Richardson,  TX  75081
Correspondent Contact Yulia Nikova
Regulation Number874.4250
Classification Product Code
ERL  
Subsequent Product Codes
EQJ   NLY  
Date Received04/25/2022
Decision Date 11/02/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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