The following data is part of a premarket notification filed by Kli with the FDA for Gynecological Cysto/urethroscope.
| Device ID | K800913 |
| 510k Number | K800913 |
| Device Name: | GYNECOLOGICAL CYSTO/URETHROSCOPE |
| Classification | Urethroscope |
| Applicant | KLI 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | FGC |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-04-21 |
| Decision Date | 1980-05-14 |