The following data is part of a premarket notification filed by Humboldt Products with the FDA for Stainless Steel Pistons.
| Device ID | K823483 |
| 510k Number | K823483 |
| Device Name: | STAINLESS STEEL PISTONS |
| Classification | Prosthesis, Partial Ossicular Replacement |
| Applicant | HUMBOLDT PRODUCTS 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | ETB |
| CFR Regulation Number | 874.3450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-11-23 |
| Decision Date | 1982-12-09 |