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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 K032054
Device Name RADIONICS NASHOLD BIOPSY NEEDLE - SINGLE USE
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 Received07/02/2003
Decision Date 09/15/2003
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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