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U.S. Department of Health and Human Services

510(k) Premarket Notification
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510(k) Number K243175
Device Name Disposable Intermittent Catheter (TPU Catheter)
Applicant
Chengdu Daxan Innovative Medical Tech. Co., Ltd.
East Side Of Distribution Center 3,#566,West Section Of
Kexing Rd., Wenjiang District
Chengdu,  CN 611137
Applicant Contact Zeng Wei
Correspondent
Shanghai Truthful Information Technology Co., Ltd.
Rm. 1801, # 161 E. Lu Jiazui Rd., Pudong
Shanghai,  CN 200120
Correspondent Contact Boyle Wang
Date Received09/30/2024
Decision Date 06/26/2025
Decision Substantially Equivalent (SESE)
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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