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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 K183262
Device Name EsoCheck CCD Cell Collection Device
Applicant
Lucid Diagnostics, Inc.
One Grand Central Place, Suite 4600
New York,  NY  10165
Applicant Contact Lishan Aklog
Correspondent
Lucid Diagnostics, Inc.
One Grand Central Place, Suite 4600
New York,  NY  10165
Correspondent Contact Lishan Aklog
Regulation Number874.4710
Classification Product Code
EOX  
Date Received11/23/2018
Decision Date 06/21/2019
Decision Substantially Equivalent - Kit (SESK)
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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