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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 K992457
Device Name SNN SYSTEM WITH OLIVIER DOUBLE CHUCK SUPPORT ARM OPTION
Applicant
SURGICAL NAVIGATION SPECIALISTS, INC.
6509 AIRPORT RD.
MISSISSAUGA, ONTARIO,  CA L4V 1S7
Applicant Contact CAROL NAKAGAWA
Correspondent
SURGICAL NAVIGATION SPECIALISTS, INC.
6509 AIRPORT RD.
MISSISSAUGA, ONTARIO,  CA L4V 1S7
Correspondent Contact CAROL NAKAGAWA
Regulation Number882.4560
Classification Product Code
HAW  
Date Received07/23/1999
Decision Date 08/27/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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