The following data is part of a premarket notification filed by Jedmed Instrument Co. with the FDA for Som 6v.
| Device ID | K910357 |
| 510k Number | K910357 |
| Device Name: | SOM 6V |
| Classification | Microscope, Surgical, General & Plastic Surgery |
| Applicant | JEDMED INSTRUMENT CO. 6069 LEMAY FERRY RD. St. Louis, MO 63129 |
| Contact | Craig Rapp |
| Correspondent | Craig Rapp JEDMED INSTRUMENT CO. 6069 LEMAY FERRY RD. St. Louis, MO 63129 |
| Product Code | FSO |
| CFR Regulation Number | 878.4700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-01-29 |
| Decision Date | 1991-02-19 |