510(k) K200556 ยท EZL Catheter, Retention Type, Balloon
AquaFlate Pre-Filled Sterile Water Syringe 10mL
| Applicant | H R Pharmaceuticals, Inc., York PA, US |
| Decision | Substantially Equivalent, Mar 31, 2020 |
| Received | Mar 3, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K200556
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.