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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Motor, Drill, Electric
510(k) Number K173066
Device Name OSSEODUO Shaver and Drill System
Applicant
Bien-Air Surgery SA
Rue De I'Ouest 2b
Le Noirmont,  CH 2340
Applicant Contact Adil Slimani
Correspondent
Ken Block Consulting
1201 Richardson Dr., Suite 160
Richardson,  TX  75080
Correspondent Contact Belia Juarez
Regulation Number882.4360
Classification Product Code
HBC  
Subsequent Product Code
HBE  
Date Received09/29/2017
Decision Date 06/22/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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