FDA 510(k) Application Details - K233142

Device Classification Name Esophagoscope (Flexible Or Rigid)

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510(K) Number K233142
Device Name Esophagoscope (Flexible Or Rigid)
Applicant Cyted Limited
22 Station Road
Cambridge CB1 2JD GB
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Contact Neha Goel
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Regulation Number 874.4710

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Classification Product Code EOX
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Date Received 09/27/2023
Decision Date 01/19/2024
Decision SESE - SUBST EQUIV
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

FDA Source Information for K233142


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