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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 K993673
Device Name SNN FLUORO NAVIGATION SYSTEM
Applicant
I.S.G. Technologies, Inc.
6509 Airport Rd.
Mississauga Ontario,  CA L4V 1S7
Applicant Contact DOLORES MCGIRR
Correspondent
I.S.G. Technologies, Inc.
6509 Airport Rd.
Mississauga Ontario,  CA L4V 1S7
Correspondent Contact DOLORES MCGIRR
Regulation Number882.4560
Classification Product Code
HAW  
Date Received11/01/1999
Decision Date 12/21/1999
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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