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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 K213302
Device Name exoplan
Applicant
Exocad GmbH
37, Julius-Reiber-Str.
Darmstadt,  DE 64293
Applicant Contact Tobias Turba
Correspondent
Exocad GmbH
37, Julius-Reiber-Str.
Darmstadt,  DE 64293
Correspondent Contact Tobias Turba
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received10/04/2021
Decision Date 05/03/2022
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
Recalls CDRH Recalls
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