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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Planning, Radiation Therapy Treatment
510(k) Number K180308
Device Name Prelude
Applicant
Medcom GmbH
Dolivostrasse 11
Darmstadt,  DE 64293
Applicant Contact Johannes Messow
Correspondent
Medcom GmbH
Dolivostrasse 11
Darmstadt,  DE 64293
Correspondent Contact Johannes Messow
Regulation Number892.5050
Classification Product Code
MUJ  
Subsequent Product Code
LHO  
Date Received02/02/2018
Decision Date 03/27/2018
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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