RADIONICS POLE NEEDLES


Device Classification Name

probe, radiofrequency lesion

510(k) Number K021942
Device Name RADIONICS POLE NEEDLES
Original Applicant
RADIONICS, A DIVISION OF TYCO HEALTHCARE GROUP LP
22 terry ave.
burlington, 
MA 
01803

Original Contact kevin j o’connell
Regulation Number 882.4725
Classification Product Code
GXI  
Subsequent Product Code
GXD  
Date Received 06/13/2002
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