The following data is part of a premarket notification filed by Pentax Precision Instrument Corp. with the FDA for Pentax Fc-38la & Fc-38sa Colonofiber.
| Device ID | K822846 |
| 510k Number | K822846 |
| Device Name: | PENTAX FC-38LA & FC-38SA COLONOFIBER |
| Classification | Colonoscope And Accessories, Flexible/rigid |
| Applicant | PENTAX PRECISION INSTRUMENT CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | FDF |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-09-23 |
| Decision Date | 1982-10-22 |