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510(k) K223584

Pre-Filled Normal Saline Flush Syringe by Anhui Tianyang Pharmaceutical Co., Ltd. — Product Code NGT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 12, 2023
Date Received
December 1, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Saline, Vascular Access Flush
Device Class
Class II
Regulation Number
880.5200
Review Panel
HO
Submission Type

Enhance the performance of intravascular catheters, to maintain patency of the vascular catheter when it is not in use.

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