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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 K827583
Device Name STEREOTACTIC 60 COBALT GAMMA SYSTEM--GAMMAKNIFE
Applicant
Nucletronix, Inc.
Blackburn Center
Gloucestor,  MA  01930
Applicant Contact ROY M EMANUELSON
Correspondent
Nucletronix, Inc.
Blackburn Center
Gloucestor,  MA  01930
Correspondent Contact ROY M EMANUELSON
Regulation Number892.5750
Classification Product Code
IWB  
Date Received08/30/1982
Decision Date 09/29/1982
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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