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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 K952459
Device Name MEDTRONIC MODEL 3991, 3991C, 3992, 3992C, 3993, 3993C, 3994, 3994C LEADS OR, TRANSVERSE TRIPOLAR LEADS OR, TTL
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 Received05/26/1995
Decision Date 08/30/1995
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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