The following data is part of a premarket notification filed by C. Intl. with the FDA for Proctoscope #501.
| Device ID | K790856 |
| 510k Number | K790856 |
| Device Name: | PROCTOSCOPE #501 |
| Classification | Proctoscope |
| Applicant | C. INTL. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | GCF |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1979-05-04 |
| Decision Date | 1979-05-29 |