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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Endoscopic Irrigation/Suction System
510(k) Number K231471
Device Name Air/Water Bottle Tubing, CO2 Source Tubing
Applicant
Zhejiang Chuangxiang Medical Technology Co., Ltd.
Rm. 101,201,301,401,501, Bldg. 50,
#650 Hongfeng Rd. Donghu St., Yuhang District
Hangzhou,  CN 311100
Applicant Contact Lucius Long
Correspondent
Zhejiang Chuangxiang Medical Technology Co., Ltd.
Rm. 101,201,301,401,501, Bldg. 50,
#650 Hongfeng Rd. Donghu St., Yuhang District
Hangzhou,  CN 311100
Correspondent Contact Lucius Long
Regulation Number876.1500
Classification Product Code
OCX  
Subsequent Product Code
FCX  
Date Received05/22/2023
Decision Date 09/08/2023
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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