The following data is part of a premarket notification filed by Nestor Engineering Associates, Inc. with the FDA for Millard Mouth Gag.
| Device ID | K780992 |
| 510k Number | K780992 |
| Device Name: | MILLARD MOUTH GAG |
| Classification | Gag, Mouth |
| Applicant | NESTOR ENGINEERING ASSOCIATES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KBN |
| CFR Regulation Number | 874.4420 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-06-14 |
| Decision Date | 1978-08-17 |