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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 K953742
Device Name BIFURCATED Y-EXTENSION
Applicant
MEDTRONIC VASCULAR
800 53RD AVE., N.E.
MINNEAPOLIS,  MN  55421
Applicant Contact DAVID H MUELLER
Correspondent
MEDTRONIC VASCULAR
800 53RD AVE., N.E.
MINNEAPOLIS,  MN  55421
Correspondent Contact DAVID H MUELLER
Regulation Number882.5880
Classification Product Code
GZB  
Date Received08/08/1995
Decision Date 11/19/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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