The following data is part of a premarket notification filed by Jedmed Instrument Co. with the FDA for Artus Drill #6000.
| Device ID | K803288 |
| 510k Number | K803288 |
| Device Name: | ARTUS DRILL #6000 |
| Classification | Drill, Bone, Powered |
| Applicant | JEDMED INSTRUMENT CO. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DZI |
| CFR Regulation Number | 872.4120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-12-30 |
| Decision Date | 1981-01-28 |