510(k) K231363 ยท NGT Saline, Vascular Access Flush
Hantech Pre-filled 0.9% Normal Saline Flush Syringes (Models PFS-1003, PFS-1005, PFS-1010)
| Applicant | Hantech Medical Device Co., Ltd., Ningbo, CN |
| Decision | Substantially Equivalent, Sep 27, 2023 |
| Received | May 11, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K231363
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.