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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 K203450
Device Name EsophaCap Swallowable Cellular Retrieval Device (changed from Cell-Mata)
CapNostics, LLC
9724 Colts Neck Lane
Concord,  NC  28027
Applicant Contact Martin von Dyck
CapNostics, LLC
9724 Colts Neck Lane
Concord,  NC  28027
Correspondent Contact Martin von Dyck
Regulation Number874.4710
Classification Product Code
Date Received11/23/2020
Decision Date 05/04/2021
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