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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 K972324
Device Name LEKSELL STEREOTACTIC SYSTEM
Applicant
ELEKTA INSTRUMENT AB
18140 SMOKESIGNAL DR.
SAN DIEGO,  CA  92127
Applicant Contact CAROL PATTERSON
Correspondent
ELEKTA INSTRUMENT AB
18140 SMOKESIGNAL DR.
SAN DIEGO,  CA  92127
Correspondent Contact CAROL PATTERSON
Regulation Number882.4560
Classification Product Code
HAW  
Date Received06/23/1997
Decision Date 03/02/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
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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