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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Straight
510(k) Number K212567
Device Name PVC Hydrophilic Urethral Catheter
Applicant
Chengdu Daxan Innovative Medical Tech. Co., Ltd.
Unit 6, Bldg. 1, #18, N. Bayi Rd.,
Wenjiang District
Chengdu,  CN 611135
Applicant Contact Kevin Huang
Correspondent
Chengdu Daxan Innovative Medical Tech. Co., Ltd.
Unit 6, Bldg. 1, #18, N. Bayi Rd.,
Wenjiang District
Chengdu,  CN 611135
Correspondent Contact Kevin Huang
Regulation Number876.5130
Classification Product Code
EZD  
Date Received08/16/2021
Decision Date 12/07/2022
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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