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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 K102523
Device Name MULTI-LEAD TRIALING CABLE MODEL 355531
Applicant
MEDTRONIC INC.
7000 CENTRAL AVENUE NE
MINNEAPOLIS,  MN  55432 -3576
Applicant Contact TRISHIA DWYER
Correspondent
MEDTRONIC INC.
7000 CENTRAL AVENUE NE
MINNEAPOLIS,  MN  55432 -3576
Correspondent Contact TRISHIA DWYER
Regulation Number882.5880
Classification Product Code
GZB  
Subsequent Product Code
GZF  
Date Received09/02/2010
Decision Date 10/26/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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