510(k) K904534 ยท FCE Enema Kit
ENEMA BULB
| Applicant | R.A.C., Inc., Gainesville GA, US |
| Decision | Substantially Equivalent, Dec 21, 1990 |
| Received | Oct 4, 1990 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K904534
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.