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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name system, radiation therapy, radionuclide
510(k) Number K173791
Device Name Leksell GammaPlan
Applicant
Elekta Instrument AB
Kungstensgatan 18
Stockholm,  SE 10393
Applicant Contact Matilda Forsberg
Correspondent
Elekta Instrument AB
Kungstensgatan 18
Stockholm,  SE 10393
Correspondent Contact Matilda Forsberg
Regulation Number892.5750
Classification Product Code
IWB  
Subsequent Product Code
MUJ  
Date Received12/14/2017
Decision Date 02/09/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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