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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Probe, Radiofrequency Lesion
510(k) Number K021942
Device Name RADIONICS POLE NEEDLES
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 Number882.4725
Classification Product Code
GXI  
Subsequent Product Code
GXD  
Date Received06/13/2002
Decision Date 09/11/2002
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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