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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 K063467
Device Name SMITH & NEPHEW RF CANNULAE
Applicant
Smith & Nephew, Inc.
150 Minuteman Rd.
Andover,  MA  01810
Applicant Contact MINNIE MILDWOFF
Correspondent
Smith & Nephew, Inc.
150 Minuteman Rd.
Andover,  MA  01810
Correspondent Contact MINNIE MILDWOFF
Regulation Number882.4725
Classification Product Code
GXI  
Subsequent Product Code
GXD  
Date Received10/24/2006
Decision Date 11/21/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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