The following data is part of a premarket notification filed by Jedmed Instrument Co. with the FDA for Jedmed Kp6 Colposcope.
| Device ID | K884934 |
| 510k Number | K884934 |
| Device Name: | JEDMED KP6 COLPOSCOPE |
| Classification | Colposcope (and Colpomicroscope) |
| Applicant | JEDMED INSTRUMENT CO. 1430 HANLEY INDUSTRIAL CT. St. Louis, MO 63144 |
| Contact | Craig Rapp |
| Correspondent | Craig Rapp JEDMED INSTRUMENT CO. 1430 HANLEY INDUSTRIAL CT. St. Louis, MO 63144 |
| Product Code | HEX |
| CFR Regulation Number | 884.1630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-11-28 |
| Decision Date | 1989-02-23 |