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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Nerve
510(k) Number K031510
Device Name NIM-SPINE
Applicant
Medtronic Xomed
6743 Southpoint Dr. N.
Jacksonville,  FL  32216
Applicant Contact MARTIN SARGENT
Correspondent
Citech
5200 Butler Pike
Plymouth Meeting,  PA  19462 -1298
Correspondent Contact ROBERT MOSENKIS
Regulation Number874.1820
Classification Product Code
ETN  
Subsequent Product Codes
GWF   IKN  
Date Received05/14/2003
Decision Date 06/18/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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