The following data is part of a premarket notification filed by Martin D. Lerman with the FDA for Aqualizer Mouthpiece.
| Device ID | K831793 |
| 510k Number | K831793 |
| Device Name: | AQUALIZER MOUTHPIECE |
| Classification | Positioner, Tooth, Preformed |
| Applicant | MARTIN D. LERMAN 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KMY |
| CFR Regulation Number | 872.5525 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-06-03 |
| Decision Date | 1983-08-12 |