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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 K002053
Device Name NAVITRAK SYSTEM-OPTICAL OPTION, MODEL 900.004
Applicant
Orthosoft, Inc.
80 Queen St., Suite 604
Montreal, Quebec,  CA H3C 2N5
Applicant Contact NICOLE LANDREVILLE
Correspondent
Orthosoft, Inc.
80 Queen St., Suite 604
Montreal, Quebec,  CA H3C 2N5
Correspondent Contact NICOLE LANDREVILLE
Regulation Number882.4560
Classification Product Code
HAW  
Date Received07/06/2000
Decision Date 08/03/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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