510(k) K974042 ยท FCE Enema Kit
AMSURE CLEANSING ENEMA SET
| Applicant | Amsino Intl., Inc., Pomona CA, US |
| Decision | Substantially Equivalent, Dec 19, 1997 |
| Received | Oct 24, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K974042
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.