510(k) K201776 ยท EZL Catheter, Retention Type, Balloon
Foley Balloon Catheter for Urology
| Applicant | Apollon Co., Ltd., Incheon, KR |
| Decision | Substantially Equivalent, Dec 30, 2020 |
| Received | Jun 29, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K201776
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.