510(k) K240389 ยท NEW Suture, Surgical, Absorbable, Polydioxanone
Secret Line up (FCL18100C160 FCL19100E160 FCL1990E150 FCL2190G150 ); i-Thread (FCL18100C160 FCL19100E160 FCL1990E150 FCL2190G150)
| Applicant | Hyundae Meditech Co., Ltd., Wonju-Si, KR |
| Decision | Substantially Equivalent, Mar 27, 2024 |
| Received | Feb 8, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K240389
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.