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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 K223584
Device Name Pre-Filled Normal Saline Flush Syringe
Applicant
Anhui Tianyang Pharmaceutical Co., Ltd.
46 Tiantong Rd., Tianchang City, Anhui Province
Tianchang,  CN
Applicant Contact Zhang Shunlin
Correspondent
Anhui Tianyang Pharmaceutical Co., Ltd.
46 Tiantong Rd., Tianchang City, Anhui Province
Tianchang,  CN
Correspondent Contact Zhang Shunlin
Regulation Number880.5200
Classification Product Code
NGT  
Date Received12/01/2022
Decision Date 08/12/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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