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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Peripheral Nerve, Implanted (Pain Relief)
510(k) Number K960631
Device Name MEDTRONIC MODEL 3550 ACCESSORY KIT (CONTENTS) 3550-OX
Applicant
MEDTRONIC VASCULAR
800 53RD AVE., N.E.
MINNEAPOLIS,  MN  55421
Applicant Contact JEAN PRATHER
Correspondent
MEDTRONIC VASCULAR
800 53RD AVE., N.E.
MINNEAPOLIS,  MN  55421
Correspondent Contact JEAN PRATHER
Regulation Number882.5870
Classification Product Code
GZF  
Subsequent Product Code
GZB  
Date Received02/14/1996
Decision Date 05/21/1996
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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