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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 K221310
Device Name Endoscopic Clean Connecting Tubes, Endoscopic CO2 Source Tubing
Applicant
Changzhou Endoclean Medical Device Co., Ltd.
West Side Of 4th Floor, Bldg. E2, #9 Changyang Rd.
Changzhou,  CN 213149
Applicant Contact Wang Qi
Correspondent
Changzhou Endoclean Medical Device Co., Ltd.
West Side Of 4th Floor, Bldg. E2, #9 Changyang Rd.
Changzhou,  CN 213149
Correspondent Contact Wang Qi
Regulation Number876.1500
Classification Product Code
OCX  
Subsequent Product Code
FCX  
Date Received05/05/2022
Decision Date 10/07/2022
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
Predetermined Change
Control Plan Authorized		 No
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