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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name esophagoscope (flexible or rigid)
510(k) Number K181020
Device Name Cytosponge Cell Collection Device
Covidien llc
15 Hampshire Street
Mansfield,  MA  02048
Applicant Contact Rachel Silva
Covidien llc
15 Hampshire Street
Mansfield,  MA  02048
Correspondent Contact Rachel Silva
Regulation Number874.4710
Classification Product Code
Date Received04/17/2018
Decision Date 08/16/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls