510(k) K921707 ยท EOB Nasopharyngoscope (Flexible Or Rigid)
PENTAX NASO-PHARYNGO-LARYNGOSCOPE FNL-15P2/15RP2
| Applicant | Pentax Precision Instrument Corp., Orangeburg NY, US |
| Decision | Substantially Equivalent, Jul 1, 1992 |
| Received | Apr 10, 1992 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K921707
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 28, 2016 | Pentax Medical Company Naso-Pharyngo-Laryngoscope
Intended to provide optical visualization of, therapeutic access to, the Upper Airway. This anatomy includes, but is not restricted to, the organs, tissues and subsystems: E Terminated |
EOB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.