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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 K034012
Device Name SMITH & NEPHEW RF DENERVATION PROBES & RF CANNULAE
Applicant
SMITH & NEPHEW, INC.
150 MINUTEMAN RD.
ANDOVER,  MA  01810
Applicant Contact KAREN PROVENCHER
Correspondent
SMITH & NEPHEW, INC.
150 MINUTEMAN RD.
ANDOVER,  MA  01810
Correspondent Contact KAREN PROVENCHER
Regulation Number882.4725
Classification Product Code
GXI  
Subsequent Product Code
GXD  
Date Received12/24/2003
Decision Date 03/16/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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