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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 K982570
Device Name SNN SCOUT
Applicant
I.S.G. TECHNOLOGIES, INC.
6509 AIRPORT ROAD
MISSISSAUGA, ONTARIO,  CA L4V 1S7
Applicant Contact CAROL NAKAGAWA
Correspondent
I.S.G. TECHNOLOGIES, INC.
6509 AIRPORT ROAD
MISSISSAUGA, ONTARIO,  CA L4V 1S7
Correspondent Contact CAROL NAKAGAWA
Regulation Number882.4560
Classification Product Code
HAW  
Date Received07/23/1998
Decision Date 01/13/1999
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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