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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 K914808
Device Name LEKSELL GAMMAPLAN (LGP)
Applicant
Elekta Instruments, Inc.
1926 Northlake Pkwy.
Tucker,  GA  30084
Applicant Contact RICHARD S GROME
Correspondent
Elekta Instruments, Inc.
1926 Northlake Pkwy.
Tucker,  GA  30084
Correspondent Contact RICHARD S GROME
Regulation Number892.5750
Classification Product Code
IWB  
Date Received10/25/1991
Decision Date 01/23/1992
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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