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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name drill, surgical, ent (electric or pneumatic) including handpiece
510(k) Number K081277
Device Name XPS 4000 SYSTEM, MIDAS REX LEGEND EHS SYSTEM, INTEGRATED POWER CONS0LE (IPC)
Applicant
MEDTRONIC XOMED, INC.
6743 SOUTHPOINT DR. NORTH
JACKSONVILLE,  FL  32216
Applicant Contact ANTOINE KOUCHAKJY
Correspondent
MEDTRONIC XOMED, INC.
6743 SOUTHPOINT DR. NORTH
JACKSONVILLE,  FL  32216
Correspondent Contact ANTOINE KOUCHAKJY
Regulation Number874.4250
Classification Product Code
ERL  
Date Received05/05/2008
Decision Date 09/05/2008
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
Recalls CDRH Recalls
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