510(k) K140523 ยท FED Endoscopic Access Overtube, Gastroenterology-Urology
RE-TRACE URETERAL ACCESS SHEATH, 12/14 CH/FR, LENGTH 35 CM, LENGTH 45 CM
| Applicant | Coloplast A/S, Plymouth MN, US |
| Decision | Substantially Equivalent, Jul 24, 2014 |
| Received | Mar 4, 2014 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K140523
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.