510(k) K013276 ยท EZL Catheter, Retention Type, Balloon
ALL-SILICONE FOLEY BALLOON CATHETER (TWO WAY; THREE WAY, RADIOPAQUE)
| Applicant | Sewoon Medical Co., Ltd., Deer Field IL, US |
| Decision | Substantially Equivalent, Feb 15, 2002 |
| Received | Oct 1, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K013276
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.