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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 K052418
Device Name AXXESS BUTTERFLY ANCHOR
Applicant
ADVANCED NEUROMODULATION SYSTEMS
6901 PRESTON RD.
PLANO,  TX  75024
Applicant Contact STEVE TAMSETT
Correspondent
ADVANCED NEUROMODULATION SYSTEMS
6901 PRESTON RD.
PLANO,  TX  75024
Correspondent Contact STEVE TAMSETT
Regulation Number882.5880
Classification Product Code
GZB  
Date Received09/02/2005
Decision Date 09/26/2005
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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