FDA 510(k) Application Details - K222366

Device Classification Name Esophagoscope (Flexible Or Rigid)

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510(K) Number K222366
Device Name Esophagoscope (Flexible Or Rigid)
Applicant Lucid Diagnostics, Inc.
One Grand Central Place, Suite 4600
New York, NY 10165 US
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Contact Lishan Aklog
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Regulation Number 874.4710

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Classification Product Code EOX
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Date Received 08/04/2022
Decision Date 10/26/2022
Decision SESK - SUBST EQUIV - KIT
Classification Advisory Committee EN - Ear, Nose, & Throat
Review Advisory Committee GU - Gastroenterology & Urology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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