The following data is part of a premarket notification filed by Eurodent, Inc. with the FDA for Bar & Rider, Screws, Tubes.
Device ID | K790078 |
510k Number | K790078 |
Device Name: | BAR & RIDER, SCREWS, TUBES |
Classification | Sterilizer, Boiling Water |
Applicant | EURODENT, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | ECG |
CFR Regulation Number | 872.6710 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1979-01-10 |
Decision Date | 1979-02-27 |