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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name system, imaging, gastrointestinal, wireless, capsule
510(k) Number K221590
Device Name NaviCam Small Bowel Capsule Endoscopy System
Applicant
ANKON Technologies Co., Ltd.
B3-2, B3-3, D3-4 Biolake, No.666, Hi-Tech Road
Wuhan,  CN 430075
Applicant Contact Si Feng Wang
Correspondent
ProMedoss Inc
3521 Hatwynn Road
Charlotte,  NC  28269
Correspondent Contact Shoshana Friedman
Regulation Number876.1300
Classification Product Code
NEZ  
Date Received06/02/2022
Decision Date 12/02/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Clinical Trials NCT05086471
NCT05308498
Reviewed by Third Party No
Combination Product No
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