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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name electrode, needle
510(k) Number K990793
Device Name ACCUGUIDE MUSCLE INJECTION MONITOR
Applicant
MEDTRONIC XOMED
6743 SOUTHPOINT DR. NORTH
JACKSONVILLE,  FL  32216
Applicant Contact DAVID TIMLIN
Correspondent
MEDTRONIC XOMED
6743 SOUTHPOINT DR. NORTH
JACKSONVILLE,  FL  32216
Correspondent Contact DAVID TIMLIN
Regulation Number882.1350
Classification Product Code
GXZ  
Subsequent Product Codes
IKN   IKT  
Date Received03/10/1999
Decision Date 10/22/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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