510(k) K951576 ยท FAM Sigmoidoscope And Accessories, Flexible/Rigid
FS-34P2, FIBER SIGMOIDOSCOPE
| Applicant | Pentax Precision Instrument Corp., Miramar FL, US |
| Decision | Substantially Equivalent, Jun 29, 1995 |
| Received | Apr 4, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K951576
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.