The following data is part of a premarket notification filed by Jedmed Instrument Co. with the FDA for Artus Drill #2000.
Device ID | K803291 |
510k Number | K803291 |
Device Name: | ARTUS DRILL #2000 |
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 |