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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 K010542
Device Name SNN SYSTEM INCLUDING THE TOMOGUIDE OPTION
Applicant
SURGICAL NAVIGATION SPECIALISTS, INC.
6509 AIRPORT ROAD
MISSISSAUGA ONTARIO,  CA L4V 1S7
Applicant Contact CAROL NAKAGAWA
Correspondent
SURGICAL NAVIGATION SPECIALISTS, INC.
6509 AIRPORT ROAD
MISSISSAUGA ONTARIO,  CA L4V 1S7
Correspondent Contact CAROL NAKAGAWA
Regulation Number882.4560
Classification Product Code
HAW  
Date Received02/23/2001
Decision Date 05/08/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
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