The following data is part of a premarket notification filed by Microtek Medical, Inc. with the FDA for Microtek Stainless Steel Piston.
| Device ID | K860460 |
| 510k Number | K860460 |
| Device Name: | MICROTEK STAINLESS STEEL PISTON |
| Classification | Prosthesis, Partial Ossicular Replacement |
| Applicant | MICROTEK MEDICAL, INC. POST OFFICE BOX 2487 Columbus, MS 39704 |
| Contact | Frank Lockhart |
| Correspondent | Frank Lockhart MICROTEK MEDICAL, INC. POST OFFICE BOX 2487 Columbus, MS 39704 |
| Product Code | ETB |
| CFR Regulation Number | 874.3450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-02-06 |
| Decision Date | 1986-07-11 |