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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 K924849
Device Name LEKSELL GAMMA UNIT MODEL 23004,TYPE B.
Applicant
Elekta Radiosurgery, Inc.
8 Executive Park W.
Atlanta,  GA  30329
Applicant Contact THOMAS PARKER
Correspondent
Elekta Radiosurgery, Inc.
8 Executive Park W.
Atlanta,  GA  30329
Correspondent Contact THOMAS PARKER
Regulation Number892.5750
Classification Product Code
IWB  
Date Received09/28/1992
Decision Date 11/20/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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