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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 K932948
Device Name MEDTRONIC MODEL 3625 SCREENER SYSTEM
Applicant
Medtronic Vascular
800 53rd Ave., NE
P.O. Box 1250
Minneapolis,  MN  55440
Applicant Contact DAVID MUELLER
Correspondent
Medtronic Vascular
800 53rd Ave., NE
P.O. Box 1250
Minneapolis,  MN  55440
Correspondent Contact DAVID MUELLER
Regulation Number882.5880
Classification Product Code
GZB  
Date Received06/17/1993
Decision Date 02/03/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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