The following data is part of a premarket notification filed by Jedmed Instrument Co. with the FDA for Dorc Adjustable Image Contacts.
| Device ID | K830169 |
| 510k Number | K830169 |
| Device Name: | DORC ADJUSTABLE IMAGE CONTACTS |
| Classification | Prism, Gonioscopic |
| Applicant | JEDMED INSTRUMENT CO. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | HKS |
| CFR Regulation Number | 886.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-01-18 |
| Decision Date | 1983-02-07 |