The following data is part of a premarket notification filed by Vacudent Sales Corp. with the FDA for Vacudent Lumix 70.
| Device ID | K800575 |
| 510k Number | K800575 |
| Device Name: | VACUDENT LUMIX 70 |
| Classification | Clasp, Preformed |
| Applicant | VACUDENT SALES CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | EHP |
| CFR Regulation Number | 872.3285 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-03-14 |
| Decision Date | 1980-05-20 |