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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 K936099
Device Name NEUROLOGICAL LEAD ACCESSORIES
Applicant
MEDTRONIC VASCULAR
800 53RD AVENUE, NE
P.O. BOX 1250
MINNEAPOLIS,  MN  55440 -9087
Applicant Contact DAVID H MUELLER
Correspondent
MEDTRONIC VASCULAR
800 53RD AVENUE, NE
P.O. BOX 1250
MINNEAPOLIS,  MN  55440 -9087
Correspondent Contact DAVID H MUELLER
Regulation Number882.5880
Classification Product Code
GZB  
Date Received12/22/1993
Decision Date 07/11/1994
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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