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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Neurological Stereotaxic Instrument
510(k) Number K852477
Device Name KELLY-GROERSS-KALL CT STEROTACTIC ADAPTATION SYS
Applicant
Mayo Clinic
Rochester,  MN  55905
Applicant Contact KALL, M.S.
Correspondent
Mayo Clinic
Rochester,  MN  55905
Correspondent Contact KALL, M.S.
Regulation Number882.4560
Classification Product Code
HAW  
Date Received06/11/1985
Decision Date 07/30/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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