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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 K083720
Device Name OSSEODUO, SHAVER HANDPIECE S80 AND S120, MICROMOTOR 80K
Applicant
Bien-Air Surgery Sa
Rue De L'Ouest 2b
Le Noirmont,  CH 2340
Applicant Contact HUGUES FROIDEVAUX
Correspondent
Bien-Air Surgery Sa
Rue De L'Ouest 2b
Le Noirmont,  CH 2340
Correspondent Contact HUGUES FROIDEVAUX
Regulation Number874.4250
Classification Product Code
ERL  
Date Received12/15/2008
Decision Date 03/20/2009
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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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