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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 K051773
Device Name MODEL 3873 1* 8 AND MODEL 3874 1* 8 COMPACT TEST STIMULATION LEADS
Applicant
MEDTRONIC INC.,NEUROLOGICAL DIVISION
710 MEDTRONIC PKWY.
MINNEAPOLIS,  MN  55432
Applicant Contact PAULA CORDERO
Correspondent
MEDTRONIC INC.,NEUROLOGICAL DIVISION
710 MEDTRONIC PKWY.
MINNEAPOLIS,  MN  55432
Correspondent Contact PAULA CORDERO
Regulation Number882.5880
Classification Product Code
GZB  
Date Received07/01/2005
Decision Date 07/28/2005
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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