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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 K992946
Device Name RENEW RECEIVER
Applicant
Advanced Neuromodulation Systems
6501 Windcrest Dr. Suite 100
Plano,  TX  75024
Applicant Contact KATRYNA WARREN
Correspondent
Advanced Neuromodulation Systems
6501 Windcrest Dr. Suite 100
Plano,  TX  75024
Correspondent Contact KATRYNA WARREN
Regulation Number882.5880
Classification Product Code
GZB  
Date Received09/01/1999
Decision Date 09/24/1999
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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