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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 K130545
Device Name MULTI LEAD TRIAL CABLE
Applicant
ST. JUDE MEDICAL
6901 PRESTON ROAD
PLANO,  TX  75024
Applicant Contact Lakshmi Padmanabhan
Correspondent
ST. JUDE MEDICAL
6901 PRESTON ROAD
PLANO,  TX  75024
Correspondent Contact Lakshmi Padmanabhan
Regulation Number882.5880
Classification Product Code
GZB  
Subsequent Product Code
GZF  
Date Received03/01/2013
Decision Date 06/18/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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