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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. N.
Jacksonville,  FL  32216
Applicant Contact MARTIN D SARGENT
Correspondent
Underwriters Laboratories, Inc.
12 Laboratory Dr.
Research Triangel Park,  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
Predetermined Change
Control Plan Authorized		 No
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