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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 K010548
Device Name MODIFICATION TO OPTICAL TRACKING SYSTEM (OTS)
Applicant
RADIONICS, A DIVISION OF TYCO HEALTHCARE GROUP LP
22 TERRY AVE.
BURLINGTON,  MA  01803
Applicant Contact KEVIN J O'CONNELL
Correspondent
RADIONICS, A DIVISION OF TYCO HEALTHCARE GROUP LP
22 TERRY AVE.
BURLINGTON,  MA  01803
Correspondent Contact KEVIN J O'CONNELL
Regulation Number882.4560
Classification Product Code
HAW  
Date Received02/26/2001
Decision Date 03/12/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Special
Reviewed by Third Party No
Combination Product No
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