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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Stimulator, Peripheral Nerve, Implanted (Pain Relief)
510(k) Number K925952
Device Name MEDTRONIC MODEL 3990 PNS LEAD
Applicant
MEDTRONIC VASCULAR
7000 CENTRAL AVE. N.E.
MINNEAPOLIS,  MN  55432
Applicant Contact DAVID H MUELLER
Correspondent
MEDTRONIC VASCULAR
7000 CENTRAL AVE. N.E.
MINNEAPOLIS,  MN  55432
Correspondent Contact DAVID H MUELLER
Regulation Number882.5870
Classification Product Code
GZF  
Date Received11/24/1992
Decision Date 08/20/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
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