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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 K960714
Device Name ISG VIEWING WAND
Applicant
I.S.G. TECHNOLOGIES, INC.
6509 AIRPORT ROAD
MISSISSAUGA, ONTARIO,  CA L4V 1S7
Applicant Contact ROBIN A OWEN
Correspondent
I.S.G. TECHNOLOGIES, INC.
6509 AIRPORT ROAD
MISSISSAUGA, ONTARIO,  CA L4V 1S7
Correspondent Contact ROBIN A OWEN
Regulation Number882.4560
Classification Product Code
HAW  
Date Received02/21/1996
Decision Date 05/29/1996
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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