PENTAX NASO-PHARYNGO-LARYNGOSCOPE FNL-15P2/15RP2
FDA 510(k) clearance K921707 · decided 1992-07-01
Clearance details
- K-number
- K921707
- Device name
- PENTAX NASO-PHARYNGO-LARYNGOSCOPE FNL-15P2/15RP2
- Applicant
- Pentax Precision Instrument Corp.
- Decision
- Substantially Equivalent
- Date received
- 1992-04-10
- Decision date
- 1992-07-01
- Days to decision
- 82 days
- Clearance type
- Traditional
- Product code
- EOB
- Device class
- 2
- Regulation number
- 874.4760
- Medical specialty
- Ear, Nose, Throat
- Advisory committee
- Ear, Nose, Throat
- Location
- Orangeburg, NY, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Naso-Pharyngo-Laryngoscope Intended to provide optical visualization of, therapeutic acces recall (Z-2074-2016) | Pentax Medical Company | 2016-06-28 |