510(k) K181445 ยท EZD Catheter, Straight
AMSure Hydrophilic Intermittent Catheter
| Applicant | Amsino International, Inc., Pomona CA, US |
| Decision | Substantially Equivalent, Oct 1, 2018 |
| Received | Jun 1, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K181445
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.