510(k) K881218 ยท FCE Enema Kit
GENT-L-KARE CLEANSING ENEMA SET
| Applicant | Geneva Laboratories, Inc., Elkhorn WI, US |
| Decision | Substantially Equivalent, Jul 28, 1988 |
| Received | Mar 22, 1988 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K881218
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.