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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 K963246
Device Name TREBAY MICRODEBRIDER OR XPS STRAIGHT SHOT
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 Number874.4250
Classification Product Code
ERL  
Date Received08/19/1996
Decision Date 09/23/1996
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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