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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 K970865
Device Name ISG FAMILY OF VIEWING WANDS
Applicant
I.S.G. Technologies, Inc.
6509 Airport Rd.
Mississauga Ontario,  CA L4V 1S7
Applicant Contact CHARLES HALL
Correspondent
I.S.G. Technologies, Inc.
6509 Airport Rd.
Mississauga Ontario,  CA L4V 1S7
Correspondent Contact CHARLES HALL
Regulation Number882.4560
Classification Product Code
HAW  
Date Received03/10/1997
Decision Date 06/04/1997
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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