The following data is part of a premarket notification filed by Midwest with the FDA for Oraluminator Iii Auto-light.
Device ID | K791771 |
510k Number | K791771 |
Device Name: | ORALUMINATOR III AUTO-LIGHT |
Classification | Light, Fiber Optic, Dental |
Applicant | MIDWEST 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | EAY |
CFR Regulation Number | 872.4620 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1979-09-07 |
Decision Date | 1979-11-20 |