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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 K021518
Device Name PAINDOC
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 Received05/10/2002
Decision Date 06/06/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
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