The following data is part of a premarket notification filed by Pentax Precision Instrument Corp. with the FDA for Pentax Upper G.i. Fiberscope, #fg-34.
| Device ID | K810007 |
| 510k Number | K810007 |
| Device Name: | PENTAX UPPER G.I. FIBERSCOPE, #FG-34 |
| Classification | Endoscope, Fiber Optic |
| Applicant | PENTAX PRECISION INSTRUMENT CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | GDB |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-01-05 |
| Decision Date | 1981-01-15 |