510(k) K990509 ยท EZL Catheter, Retention Type, Balloon
OLIGON FOLEY CATHETER (16 FR) #33816/OLIGON FOLEY CATHETER (18 FR) #33818
| Applicant | Implemed, Inc., Watertown MA, US |
| Decision | Substantially Equivalent, May 18, 1999 |
| Received | Feb 18, 1999 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K990509
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.