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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 K990632
Device Name OPTICAL TRACKING SYSTEM (OTS)
Applicant
RADIONICS, INC.
22 TERRY AVE.
BURLINGTON,  MA  01803 -2516
Applicant Contact LISA MISTERKA BENATI
Correspondent
RADIONICS, INC.
22 TERRY AVE.
BURLINGTON,  MA  01803 -2516
Correspondent Contact LISA MISTERKA BENATI
Regulation Number882.4560
Classification Product Code
HAW  
Date Received02/26/1999
Decision Date 04/29/1999
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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