510(k) K231363

Device: Hantech Pre-filled 0.9% Normal Saline Flush Syringes (Models PFS-1003, PFS-1005, PFS-1010)
Applicant: Hantech Medical Device Co., Ltd.
510(k) number: K231363
Product code: NGT
Decision: Substantially Equivalent (SESE)
Decision date: 2023-09-27
Date received: 2023-05-11
Regulation: 880.5200
Classification name: Saline, Vascular Access Flush
Medical specialty: General Hospital
Review panel: General Hospital
Device class: 2
Clearance type: Traditional
Statement or summary: Summary
Third party reviewed: No

Applicant Contact#

Contact: Arnold Yang
Address: No 288 Sanheng Rd., Changhe Industrial Park, Cixi Ningbo CN 315326 315326