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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name stimulator, peripheral nerve, implanted (pain relief)
510(k) Number K000852
Device Name RENEW NEUROSTIMULATION SYSTEM
Applicant
ADVANCED NEUROMODULATION SYSTEMS
6501 WINDCREST DRIVE SUITE 100
PLANO,  TX  75024
Applicant Contact RASHMI MOZA
Correspondent
ADVANCED NEUROMODULATION SYSTEMS
6501 WINDCREST DRIVE SUITE 100
PLANO,  TX  75024
Correspondent Contact RASHMI MOZA
Regulation Number882.5870
Classification Product Code
GZF  
Subsequent Product Code
GZB  
Date Received03/15/2000
Decision Date 01/19/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
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