The following data is part of a premarket notification filed by Pentax Precision Instrument Corp. with the FDA for Pentex Upper G.i. Scope Model Fg-28a.
| Device ID | K792215 |
| 510k Number | K792215 |
| Device Name: | PENTEX UPPER G.I. SCOPE MODEL FG-28A |
| Classification | Light Source, Endoscope, Xenon Arc |
| Applicant | PENTAX PRECISION INSTRUMENT CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | GCT |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1979-11-05 |
| Decision Date | 1979-12-10 |