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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.
# 38 Beiguandu Rd.
Suzhou,  CN 215000
Applicant Contact Aline Qin
Correspondent
Suzhou Beyo Medical Technology Co., Ltd.
# 38 Beiguandu Rd.
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
Predetermined Change
Control Plan Authorized		 No
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