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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 K943468
Device Name LEKSELL SURGIPLAN
Applicant
Elekta Instruments, Inc.
8 Executive Park W.
Atlanta,  GA  30329
Applicant Contact TOM PARKER
Correspondent
Elekta Instruments, Inc.
8 Executive Park W.
Atlanta,  GA  30329
Correspondent Contact TOM PARKER
Regulation Number882.4560
Classification Product Code
HAW  
Date Received07/19/1994
Decision Date 01/20/1995
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
Recalls CDRH Recalls
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