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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 K002224
Device Name XPS 3000 SYSTEM
Applicant
MEDTRONIC XOMED
6743 SOUTHPOINT DR. NORTH
JACKSONVILLE,  FL  32216
Applicant Contact MARTIN D SARGENT
Correspondent
MEDTRONIC XOMED
6743 SOUTHPOINT DR. NORTH
JACKSONVILLE,  FL  32216
Correspondent Contact MARTIN D SARGENT
Regulation Number874.4250
Classification Product Code
ERL  
Date Received07/24/2000
Decision Date 12/04/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Type Traditional
Reviewed by Third Party No
Combination Product No
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