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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Saline, Vascular Access Flush
510(k) Number K230756
Device Name TK Pre-Filled Normal Saline Flush Syringe
Applicant
Anhui Tiankang Medical Technology Co., Ltd.
# 228 Weiyi Rd., Economic Development Zone
Tianchang,  CN
Applicant Contact Bai Baodong
Correspondent
Share Info (Guangzhou) Medical Consultant , Ltd.
# 1919-1920, Bldg. D3, Minjie Plaza, Shuixi Rd.,
Huangpu District
Guangzhou,  CN
Correspondent Contact Cassie Lee
Regulation Number880.5200
Classification Product Code
NGT  
Date Received03/20/2023
Decision Date 08/12/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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