510(k) K103371 ยท EZL Catheter, Retention Type, Balloon
COUDE/ OR TIEMANN
| Applicant | Degania Silicone , Ltd., Emek Hayarden, IL |
| Decision | Substantially Equivalent, Mar 11, 2011 |
| Received | Nov 17, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K103371
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.