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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 K983603
Device Name REFLECTIVE SPHERE STANDARD PROBE AND REFLECTIVE SPHERE DYNAMIC REFERENCE FRAME
Applicant
Radionics, Inc.
22 Terry Ave.
Burlington,  MA  01803
Applicant Contact KEVIN O'CONNELL
Correspondent
Radionics, Inc.
22 Terry Ave.
Burlington,  MA  01803
Correspondent Contact KEVIN O'CONNELL
Regulation Number882.4560
Classification Product Code
HAW  
Date Received10/14/1998
Decision Date 11/10/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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