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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 K974602
Device Name OPTICAL TRACKING SYSTEM (OTS)
Applicant
Radionics Software Applications, Inc.
22 Terry Ave.
Burlington,  MA  01803
Applicant Contact LISA M BENATI
Correspondent
Radionics Software Applications, Inc.
22 Terry Ave.
Burlington,  MA  01803
Correspondent Contact LISA M BENATI
Regulation Number882.4560
Classification Product Code
HAW  
Date Received12/09/1997
Decision Date 04/21/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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