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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 K062041
Device Name MODEL 3875 1 X 8 SC TEST STIMULATION LEAD
Applicant
MEDTRONIC INC.
710 MEDTRONIC PARKWAY
MAIL STOP LN145
MINNEAPOLIS,  MN  55432
Applicant Contact PAULA CORDERO
Correspondent
MEDTRONIC INC.
710 MEDTRONIC PARKWAY
MAIL STOP LN145
MINNEAPOLIS,  MN  55432
Correspondent Contact PAULA CORDERO
Regulation Number882.5880
Classification Product Code
GZB  
Date Received07/19/2006
Decision Date 08/16/2006
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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