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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 K203696
Device Name RBknee
Applicant
Radiobotics ApS
Strandstrassde 21 4. th
Copenhagen,  DK DK1255
Applicant Contact Martin Christian Axelsen
Correspondent
Hogan Lovells US LLP
555 13th Street, NW
Washington,  DC  20004
Correspondent Contact John J. Smith
Regulation Number892.2050
Classification Product Code
LLZ  
Subsequent Product Code
JAK  
Date Received12/18/2020
Decision Date 08/27/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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