510(k) K220434 ยท PLL Submucosal Injection Agent
Blue Eye (TS-905)
| Applicant | The Standard Co., Ltd., Gunpo-Si, KR |
| Decision | Substantially Equivalent, Aug 12, 2022 |
| Received | Feb 15, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K220434
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.