The following data is part of a premarket notification filed by Leonard Russo Co. with the FDA for Soft Plate Cushion.
| Device ID | K813190 |
| 510k Number | K813190 |
| Device Name: | SOFT PLATE CUSHION |
| Classification | Cushion, Denture, Over The Counter |
| Applicant | LEONARD RUSSO CO. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | EHS |
| CFR Regulation Number | 872.3540 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-11-16 |
| Decision Date | 1982-02-05 |