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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Spinal-Cord, Implanted (Pain Relief)
510(k) Number K022222
Device Name LAMITRODE S-SERIES (S4 AND S8) LEADS
Applicant
Advanced Neuromodulation System,Inc
6501 Windcrest Dr.,Sute 100
Plano,  TX  75024
Applicant Contact KATRYNA WARREN
Correspondent
Advanced Neuromodulation System,Inc
6501 Windcrest Dr.,Sute 100
Plano,  TX  75024
Correspondent Contact KATRYNA WARREN
Regulation Number882.5880
Classification Product Code
GZB  
Date Received07/09/2002
Decision Date 08/08/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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