The following data is part of a premarket notification filed by Jedmed Instrument Co. with the FDA for Dorc Contact/photo Deratoscope.
| Device ID | K830290 |
| 510k Number | K830290 |
| Device Name: | DORC CONTACT/PHOTO DERATOSCOPE |
| Classification | Photokeratoscope |
| Applicant | JEDMED INSTRUMENT CO. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | HJA |
| CFR Regulation Number | 886.1350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-01-27 |
| Decision Date | 1983-03-09 |