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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 K030118
Device Name RAPID PROGRAMMAR
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 Number882.5880
Classification Product Code
GZB  
Date Received01/13/2003
Decision Date 03/11/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Statement Statement
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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