510(k) K010607 ยท LJH System, Irrigation, Urological
MED-RX IRRIGATION SET, MODEL 10-3001, 10-3002, 10-4000, 10-4001
| Applicant | Benlan, Inc., Oakville, CA |
| Decision | Substantially Equivalent, Nov 28, 2001 |
| Received | Mar 1, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K010607
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 11, 2022 | Canadian Hospital Specialties MED-RX UROLOGICAL CYSTO/BLADDER IRRIGATION SET, REF 10-4001 Terminated |
LJH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.