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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Endoscope Channel Accessory
510(k) Number K232244
Device Name Disposable Endoscope Valves System
Applicant
Changzhou Endoclean Medical Device Co., Ltd.
West Side Of 4th Floor, Bldg. E2, #9 Changyang Rd., W.
Taihu Science And Technology Industrial Park, Wujin Disrict
Changzhou,  CN 213149
Applicant Contact Qi Wang
Correspondent
Changzhou Endoclean Medical Device Co., Ltd.
West Side Of 4th Floor, Bldg. E2, #9 Changyang Rd., W.
Taihu Science And Technology Industrial Park, Wujin Disrict
Changzhou,  CN 213149
Correspondent Contact Qi Wang
Regulation Number876.1500
Classification Product Code
ODC  
Date Received07/28/2023
Decision Date 11/29/2023
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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