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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 K014165
Device Name STIMULUS - DISSECTION INSTRUMENTS
Applicant
MEDTRONIC XOMED, INC.
6743 SOUTHPOINT DR. NORTH
JACKSONVILLE,  FL  32216
Applicant Contact MARTIN D SARGENT
Correspondent
MEDTRONIC XOMED, INC.
6743 SOUTHPOINT DR. NORTH
JACKSONVILLE,  FL  32216
Correspondent Contact MARTIN D SARGENT
Regulation Number874.1820
Classification Product Code
ETN  
Date Received12/19/2001
Decision Date 01/22/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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