510(k) K233954 ยท ELW Material, Impression
Chemi-SiL (HB, MB, LB, LBS); Chemi-SiL Bite-Blu
| Applicant | B&E Korea Co., Ltd., Hwaseong-Si, KR |
| Decision | Substantially Equivalent, Feb 13, 2024 |
| Received | Dec 15, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K233954
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.