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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name endoscopic cytology brush
510(k) Number K220063
Device Name Single Use Cytology Brush
Applicant
Zhejiang Chuangxiang Medical Technology Co., Ltd.
Room 101, 201, 301, 401, 501, Building 50, No.650 Hongfeng
Road Donghu Street, Yuhang District
Hangzhou,  CN 311100
Applicant Contact Lucius Long
Correspondent
Zhejiang Chuangxiang Medical Technology Co., Ltd.
Room 101, 201, 301, 401, 501, Building 50, No.650 Hongfeng
Road Donghu Street, Yuhang District
Hangzhou,  CN 311100
Correspondent Contact Lucius Long
Regulation Number876.1500
Classification Product Code
FDX  
Date Received01/10/2022
Decision Date 07/28/2022
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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