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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 K050922
Device Name ANS SCS ACCESSORY KIT
Applicant
Advanced Neuromodulation Systems
6901 Preston Rd.
Plano,  TX  75024
Applicant Contact DANIELLE ALARCON
Correspondent
Advanced Neuromodulation Systems
6901 Preston Rd.
Plano,  TX  75024
Correspondent Contact DANIELLE ALARCON
Regulation Number882.5880
Classification Product Code
GZB  
Date Received04/13/2005
Decision Date 05/18/2005
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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