The following data is part of a premarket notification filed by Pentax Precision Instrument Corp. with the FDA for Pentax Naso-pharyngo-laryngoscope Fnl-15p2/15rp2.
| Device ID | K921707 |
| 510k Number | K921707 |
| Device Name: | PENTAX NASO-PHARYNGO-LARYNGOSCOPE FNL-15P2/15RP2 |
| Classification | Nasopharyngoscope (flexible Or Rigid) |
| Applicant | PENTAX PRECISION INSTRUMENT CORP. 30 RAMLAND RD. Orangeburg, NY 10962 |
| Contact | Lorraine Schwartz |
| Correspondent | Lorraine Schwartz PENTAX PRECISION INSTRUMENT CORP. 30 RAMLAND RD. Orangeburg, NY 10962 |
| Product Code | EOB |
| CFR Regulation Number | 874.4760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-04-10 |
| Decision Date | 1992-07-01 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04961333232789 | K921707 | 000 |
| 04961333232758 | K921707 | 000 |
| 04961333224401 | K921707 | 000 |
| 04961333224272 | K921707 | 000 |
| 04961333171262 | K921707 | 000 |