510(k) K130908 ยท EZL Catheter, Retention Type, Balloon
DISPOSABLE SILICONE FOLEY CATHETER
| Applicant | Guangdong Baihe Medical Technology Co., Ltd., Shanghai, CN |
| Decision | Substantially Equivalent, Oct 3, 2013 |
| Received | Apr 1, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K130908
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.