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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 K032349
Device Name PLACER
Applicant
Advanced Neuromodulation Systems
6501 Windcrest Dr. Suite 100
Plano,  TX  75024
Applicant Contact KATRYNA WARREN
Correspondent
Advanced Neuromodulation Systems
6501 Windcrest Dr. Suite 100
Plano,  TX  75024
Correspondent Contact KATRYNA WARREN
Regulation Number882.5880
Classification Product Code
GZB  
Date Received06/30/2003
Decision Date 10/03/2003
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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