510(k) K200638 ยท HET Laparoscope, Gynecologic (And Accessories)
LAP-iX Suction Irrigation
| Applicant | Sejong Medical Co., Ltd., Paju-Si, KR |
| Decision | Substantially Equivalent, Apr 3, 2020 |
| Received | Mar 10, 2020 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K200638
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.