The following data is part of a premarket notification filed by Elmed, Inc. with the FDA for Kolposkop Kp20005.
| Device ID | K791279 |
| 510k Number | K791279 |
| Device Name: | KOLPOSKOP KP20005 |
| Classification | Colposcope (and Colpomicroscope) |
| Applicant | ELMED, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | HEX |
| CFR Regulation Number | 884.1630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1979-07-10 |
| Decision Date | 1979-09-17 |