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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 K152794
Device Name Cytosponge Cell Collection Device
Covidien LLC
15 Hampshire Street
Mansfield,  MA  02040 8
Applicant Contact Clare Santulli
Covidien LLC
15 Hampshire Street
Mansfield,  MA  02040 -0008
Correspondent Contact Saket Bhatt
Regulation Number874.4710
Classification Product Code
Date Received09/28/2015
Decision Date 04/12/2016
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