The following data is part of a premarket notification filed by Pentax Precision Instrument Corp. with the FDA for Pentax Flexible Driodenofiberscope.
| Device ID | K812810 |
| 510k Number | K812810 |
| Device Name: | PENTAX FLEXIBLE DRIODENOFIBERSCOPE |
| Classification | Panendoscope (gastroduodenoscope) |
| Applicant | PENTAX PRECISION INSTRUMENT CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | FAK |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-10-06 |
| Decision Date | 1981-11-17 |