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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 K090907
Device Name PENTA LEAD KITS, MODELS: 3227-3234
Applicant
Advanced Neuromodulation Systems
6901 Preston Rd.
Plano,  TX  75024
Applicant Contact AMY CLENDENING
Correspondent
Advanced Neuromodulation Systems
6901 Preston Rd.
Plano,  TX  75024
Correspondent Contact AMY CLENDENING
Regulation Number882.5880
Classification Product Code
GZB  
Date Received04/01/2009
Decision Date 06/02/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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