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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 K991636
Device Name ELEKTA STEREOTACTIC GUIDE
Applicant
ELEKTA INSTRUMENT AB
21911 ERIE LN.
LAKE FOREST,  CA  92630
Applicant Contact CAROL PATTERSON
Correspondent
ELEKTA INSTRUMENT AB
21911 ERIE LN.
LAKE FOREST,  CA  92630
Correspondent Contact CAROL PATTERSON
Regulation Number882.4560
Classification Product Code
HAW  
Date Received05/12/1999
Decision Date 07/20/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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