510(k) K980868 ยท KPL Colonic Irrigation System
GC IRRIGATOR
| Applicant | Gentle Colonics, Inc., Irvine CA, US |
| Decision | Substantially Equivalent, Aug 6, 1998 |
| Received | Mar 6, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K980868
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.