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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 K032751
Device Name MODIFICATION TO RENEW LEAD EXTENSION
Applicant
Advanced Neuromodulation Systems
6501 Windcrest Dr. Suite 100
Plano,  TX  75024
Applicant Contact DANIELLE ALARCON
Correspondent
Advanced Neuromodulation Systems
6501 Windcrest Dr. Suite 100
Plano,  TX  75024
Correspondent Contact DANIELLE ALARCON
Regulation Number882.5880
Classification Product Code
GZB  
Date Received09/05/2003
Decision Date 10/06/2003
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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