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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name bur, ear, nose and throat
510(k) Number K041985
Device Name XPS CURVED BUR
Applicant
MEDTRONIC XOMED, INC.
6743 SOUTHPOINT DR. NORTH
JACKSONVILLE,  FL  32216
Applicant Contact MARTIN D SARGENT
Correspondent
UNDERWRITERS LABORATORIES, INC.
12 LABORATORY DR.
RESEARCH TRIANGLE,  NC  27709
Correspondent Contact WILLIAM J SAMMONS
Regulation Number874.4140
Classification Product Code
EQJ  
Date Received07/23/2004
Decision Date 08/12/2004
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
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