510(k) K123475 ยท DYB Introducer, Catheter
SHOOCIN INTRODUCER KIT
| Applicant | Lepu Medical Technology (Beijing) Co., Ltd., South Euclid OH, US |
| Decision | Substantially Equivalent, Feb 3, 2014 |
| Received | Nov 13, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K123475
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.