The following data is part of a premarket notification filed by Microbio-medics, Inc. with the FDA for Microtek Total Ossicular Prothesis.
| Device ID | K895815 |
| 510k Number | K895815 |
| Device Name: | MICROTEK TOTAL OSSICULAR PROTHESIS |
| Classification | Replacement, Ossicular Prosthesis, Total |
| Applicant | MICROBIO-MEDICS, INC. POST OFFICE BOX 2487 Columbus, MS 39704 |
| Contact | Keith Mcgee |
| Correspondent | Keith Mcgee MICROBIO-MEDICS, INC. POST OFFICE BOX 2487 Columbus, MS 39704 |
| Product Code | ETA |
| CFR Regulation Number | 874.3495 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-09-29 |
| Decision Date | 1989-12-26 |