The following data is part of a premarket notification filed by Mednet Locator, Inc. with the FDA for Partial Ossicular Replacement Prosthesis (porp).
| Device ID | K972734 |
| 510k Number | K972734 |
| Device Name: | PARTIAL OSSICULAR REPLACEMENT PROSTHESIS (PORP) |
| Classification | Prosthesis, Partial Ossicular Replacement |
| Applicant | MEDNET LOCATOR, INC. 7000 SHADOW OAKS Memphis, TN 38125 |
| Contact | Judy S Chandler |
| Correspondent | Judy S Chandler MEDNET LOCATOR, INC. 7000 SHADOW OAKS Memphis, TN 38125 |
| Product Code | ETB |
| CFR Regulation Number | 874.3450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-07-22 |
| Decision Date | 1997-09-05 |