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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name endoscopic access overtube, gastroenterology-urology
510(k) Number K203165
Device Name Disposable Ureteral Access Sheath
Applicant
Suzhou Beyo Medical Technology Co., Ltd.
No. 38 Beiguandu Road
Suzhou,  CN 215000
Applicant Contact Aline Qin
Correspondent
Suzhou Beyo Medical Technology Co., Ltd.
No. 38 Beiguandu Road
Suzhou,  CN 215000
Correspondent Contact Aline Qin
Regulation Number876.1500
Classification Product Code
FED  
Date Received10/23/2020
Decision Date 04/30/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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