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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 K210137
Device Name EsoCheck Cell Collection Device
Applicant
Lucid Diagnostics, Inc.
One Grand Central Place, Suite 4600
New York,  NY  10165
Applicant Contact Lishan Aklog
Correspondent
Hogan Lovells US LLP
1735 Market Street, 23rd Floor
Philadelphia,  PA  19103
Correspondent Contact Janice Hogan
Regulation Number874.4710
Classification Product Code
EOX  
Date Received01/19/2021
Decision Date 02/18/2021
Decision Substantially Equivalent - Kit (SESK)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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