The following data is part of a premarket notification filed by American Optical Corp. with the FDA for Flexible Proctosigmoidoscope, #fps-3.
| Device ID | K820790 |
| 510k Number | K820790 |
| Device Name: | FLEXIBLE PROCTOSIGMOIDOSCOPE, #FPS-3 |
| Classification | Sigmoidoscope And Accessories, Flexible/rigid |
| Applicant | AMERICAN OPTICAL CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | FAM |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-03-23 |
| Decision Date | 1982-04-01 |