510(k) K102485 ยท FED Endoscopic Access Overtube, Gastroenterology-Urology
RE-TRACE URETERAL ACCESS SHEATH
| Applicant | Coloplast A/S, Plymouth MN, US |
| Decision | Substantially Equivalent, Oct 18, 2010 |
| Received | Aug 30, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K102485
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.