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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 K981315
Device Name NAVITRACK
Applicant
ORTHOSOFT, INC.
40 BATES RD., SUITE 240
OUTREMONT, QUEBEC,  CA H2V 1A8
Applicant Contact NICOLE LANDREVILLE
Correspondent
ORTHOSOFT, INC.
40 BATES RD., SUITE 240
OUTREMONT, QUEBEC,  CA H2V 1A8
Correspondent Contact NICOLE LANDREVILLE
Regulation Number882.4560
Classification Product Code
HAW  
Date Received04/10/1998
Decision Date 07/09/1998
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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