The following data is part of a premarket notification filed by Jedmed Instrument Co. with the FDA for Microscope Model Om-p.
| Device ID | K802903 |
| 510k Number | K802903 |
| Device Name: | MICROSCOPE MODEL OM-P |
| Classification | Microscope, Surgical |
| Applicant | JEDMED INSTRUMENT CO. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | EPT |
| CFR Regulation Number | 878.4700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-11-17 |
| Decision Date | 1981-02-04 |