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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 K955291
Device Name DUALSCREEN
Applicant
Medtronic Vascular
800 53rd Ave., NE
Minneapolis,,  MN  55421
Applicant Contact DENNIS H CRANE
Correspondent
Medtronic Vascular
800 53rd Ave., NE
Minneapolis,,  MN  55421
Correspondent Contact DENNIS H CRANE
Regulation Number882.5880
Classification Product Code
GZB  
Date Received11/16/1995
Decision Date 05/17/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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