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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 K211429
Device Name NAVIPLAN - CT Planning Software for Total Hip Replacement
Applicant
Naviswiss AG
Stahlrain 2
Brugg,  CH 5200
Applicant Contact Jan Stifter
Correspondent
Confinis AG
Allee 1b
Sursee,  CH 6210
Correspondent Contact Stefano Adami
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received05/07/2021
Decision Date 10/05/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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