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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Image Processing, Radiological
510(k) Number K160407
Device Name spineEOS
Applicant
Onefit Medical
18 Rue Alain Savary
Besançon,  FR 25000
Applicant Contact JULIEN SIMON
Correspondent
Onefit Medical
18 Rue Alain Savary
Besançon,  FR 25000
Correspondent Contact JULIEN SIMON
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received02/16/2016
Decision Date 04/08/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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