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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 K972043
Device Name MEDTRONIC MODEL 3273/3274 RF RECEIVER AND MODEL 3629/3630 SCREENER
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  
Subsequent Product Code
GZF  
Date Received06/02/1997
Decision Date 08/22/1997
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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