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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 K233142
Device Name EndoSign® Cell collection device (ES-CYT-102)
Applicant
Cyted Limited
22 Station Road
Cambridge,  GB CB1 2JD
Applicant Contact Neha Goel
Correspondent
IMed Consultancy Ltd
Bloxham Mill
Bloxham,  GB OX15 4FF
Correspondent Contact Burton Matt
Regulation Number874.4710
Classification Product Code
EOX  
Date Received09/27/2023
Decision Date 01/19/2024
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
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