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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.
#10, Juncheng Rd., Eastern Area, Economic And
Technological Development
Guangzhou,  CN 510760
Applicant Contact Zoe Zeng
Correspondent
Bain Medical Equipment (Guangzhou) Co., Ltd.
#10, Juncheng Rd., 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
Predetermined Change
Control Plan Authorized		 No
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