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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name needle, fistula
510(k) Number K213015
Device Name DORA Disposable A.V. Fistula Needle Sets
Applicant
Bain Medical Equipment (Guangzhou)Co., Ltd.
No.10, Juncheng Road, Eastern Area, Economic and
Technological Development
Guangzhou,  CN 510760
Applicant Contact Zoe Zeng
Correspondent
Bain Medical Equipment (Guangzhou)Co., Ltd.
No.10, Juncheng Road, Eastern Area, Economic and
Technological Development
Guangzhou,  CN 510760
Correspondent Contact Zoe Zeng
Regulation Number876.5540
Classification Product Code
FIE  
Date Received09/20/2021
Decision Date 04/08/2022
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
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