510(k) K935531 ยท GBX Catheter, Irrigation
OP-FLEX SUMP SUCTION SET WITH DIFFUSER TIP
| Applicant | Puritas Health Care, Inc., New Milford CT, US |
| Decision | Substantially Equivalent, May 5, 1994 |
| Received | Nov 16, 1993 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K935531
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.