510(k) K905574 ยท FGD Catheter, Retention, Barium Enema With Bag
SLIM LINE RETENTION TIP W/ SILICONE RUBBER CUFF
| Applicant | E-Z-Em, Inc., Worcester MA, US |
| Decision | Substantially Equivalent, Jan 24, 1991 |
| Received | Dec 12, 1990 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K905574
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.