The following data is part of a premarket notification filed by Xomed, Inc. with the FDA for Esterm Malleus Total And Partial Middle Ear Prosthesis.
| Device ID | K964909 |
| 510k Number | K964909 |
| Device Name: | ESTERM MALLEUS TOTAL AND PARTIAL MIDDLE EAR PROSTHESIS |
| Classification | Prosthesis, Partial Ossicular Replacement |
| Applicant | XOMED, INC. 6743 SOUTHPOINT DR. NORTH Jacksonville, FL 32216 -0980 |
| Contact | David Timlin |
| Correspondent | David Timlin XOMED, INC. 6743 SOUTHPOINT DR. NORTH Jacksonville, FL 32216 -0980 |
| Product Code | ETB |
| CFR Regulation Number | 874.3450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-12-09 |
| Decision Date | 1997-03-10 |