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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name system, x-ray, stationary
510(k) Number K202394
Device Name EOSedge
Applicant
EOS imaging
10 rue Mercoeur
Paris,  FR F-75011
Applicant Contact Bernard Ismael
Correspondent
EOS imaging
10 rue Mercoeur
Paris,  FR F-75011
Correspondent Contact Bernard Ismael
Regulation Number892.1680
Classification Product Code
KPR  
Date Received08/21/2020
Decision Date 09/16/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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