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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 K964801
Device Name OPTICAL TRACKING SYSTEM (OTS)
Applicant
RADIONICS SOFTWARE APPLICATIONS, INC.
22 TERRY AVE.
BURLINGTON,  MA  01803 -0658
Applicant Contact AMY J LAFORTE, PH.D.
Correspondent
RADIONICS SOFTWARE APPLICATIONS, INC.
22 TERRY AVE.
BURLINGTON,  MA  01803 -0658
Correspondent Contact AMY J LAFORTE, PH.D.
Regulation Number882.4560
Classification Product Code
HAW  
Date Received11/29/1996
Decision Date 06/02/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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