510(k) K951197 ยท GCL Esophagoscope, General & Plastic Surgery
FE-24X, FIBER ESOPHAGOSCOPE
| Applicant | Pentax Precision Instrument Corp., Miramar FL, US |
| Decision | Substantially Equivalent, May 30, 1995 |
| Received | Mar 16, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K951197
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.