510(k) K123675 ยท FED Endoscopic Access Overtube, Gastroenterology-Urology
RE-TRACE URETERAL ACCESS SHEATH, 10/12 FRENCH, LENGTH 35 AND 45 CM, URETERAL ACCESS SHEATH, 12/14 CH-FR, LENGTH 35CM, UR
| Applicant | Coloplast A/S, Plymouth MN, US |
| Decision | Substantially Equivalent, Mar 1, 2013 |
| Received | Nov 30, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K123675
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.