510(k) K800960 ยท FCE Enema Kit
1500 ML DISPOSABLE ENEMA CONTAINER(1110)
| Applicant | The Healthcare Group Laboratories, Inc., Mchenry IL, US |
| Decision | Substantially Equivalent, May 14, 1980 |
| Received | Apr 23, 1980 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K800960
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.