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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 K982902
Device Name PERIPHERAL NERVE STIMULATION
Applicant
Medtronic Vascular
800 53rd Ave., NE
P.O. Box 1250
Minneapolis,  MN  55440
Applicant Contact DAVID H MUELLER
Correspondent
Medtronic Vascular
800 53rd Ave., NE
P.O. Box 1250
Minneapolis,  MN  55440
Correspondent Contact DAVID H MUELLER
Regulation Number882.5870
Classification Product Code
GZF  
Date Received08/14/1998
Decision Date 11/10/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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