510(k) K091767 ยท EZL Catheter, Retention Type, Balloon
3 WAY SILICONE FOLEY BALLOON CATHETER
| Applicant | Cook Urological, Inc., Spencer IN, US |
| Decision | Substantially Equivalent, Oct 9, 2009 |
| Received | Jun 17, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K091767
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.