510(k) K193339 ยท HIF Insufflator, Laparoscopic
GTK Veress Needles
| Applicant | Guangzhou T.K Medical Instrument Co., Ltd., Guangzhou, CN |
| Decision | Substantially Equivalent, Jan 30, 2020 |
| Received | Dec 2, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K193339
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.