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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 K984328
Device Name LEKSELL GAMMA KNIFE TARGET SYSTEM, MODEL 24001
Applicant
Elekta Instrument AB
181 40 Smokesignal Dr.
San Diego,  CA  92127
Applicant Contact CAROL PATTERSON
Correspondent
Elekta Instrument AB
181 40 Smokesignal Dr.
San Diego,  CA  92127
Correspondent Contact CAROL PATTERSON
Regulation Number892.5750
Classification Product Code
IWB  
Date Received12/03/1998
Decision Date 05/21/1999
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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