The following data is part of a premarket notification filed by Grace Medical, Inc. with the FDA for Stapes Prostheses.
| Device ID | K991394 |
| 510k Number | K991394 |
| Device Name: | STAPES PROSTHESES |
| Classification | Prosthesis, Partial Ossicular Replacement |
| Applicant | Grace Medical, Inc. 7731 HWY. 70, SUITE 107 Bartlett, TN 38133 |
| Contact | Anthony D Prescott |
| Correspondent | Anthony D Prescott Grace Medical, Inc. 7731 HWY. 70, SUITE 107 Bartlett, TN 38133 |
| Product Code | ETB |
| CFR Regulation Number | 874.3450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-04-21 |
| Decision Date | 1999-05-18 |