The following data is part of a premarket notification filed by Xomed, Inc. with the FDA for Titanium Middle Ear Prostheses.
| Device ID | K002897 |
| 510k Number | K002897 |
| Device Name: | TITANIUM MIDDLE EAR PROSTHESES |
| 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 | 2000-09-18 |
| Decision Date | 2000-10-11 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00763000036591 | K002897 | 000 |
| 00763000036201 | K002897 | 000 |
| 00763000036430 | K002897 | 000 |
| 00763000036812 | K002897 | 000 |
| 00763000036829 | K002897 | 000 |
| 00763000036515 | K002897 | 000 |
| 00763000036539 | K002897 | 000 |
| 00763000036546 | K002897 | 000 |
| 00763000036676 | K002897 | 000 |
| 00763000036195 | K002897 | 000 |
| 00763000036584 | K002897 | 000 |
| 00763000036607 | K002897 | 000 |
| 00763000036614 | K002897 | 000 |
| 00763000036621 | K002897 | 000 |
| 00763000036638 | K002897 | 000 |
| 00763000036645 | K002897 | 000 |
| 00763000036553 | K002897 | 000 |
| 00763000036560 | K002897 | 000 |
| 00763000036577 | K002897 | 000 |
| 00763000036683 | K002897 | 000 |
| 00885074006659 | K002897 | 000 |
| 00885074006666 | K002897 | 000 |
| 00721902848223 | K002897 | 000 |
| 00721902848230 | K002897 | 000 |
| 00721902848247 | K002897 | 000 |
| 00721902848254 | K002897 | 000 |
| 00721902848261 | K002897 | 000 |
| 00721902848278 | K002897 | 000 |
| 00721902848285 | K002897 | 000 |
| 00681490909891 | K002897 | 000 |
| 00721902848216 | K002897 | 000 |
| 00721902848209 | K002897 | 000 |
| 00885074371160 | K002897 | 000 |
| 00885074371177 | K002897 | 000 |
| 00721902720529 | K002897 | 000 |
| 00721902837937 | K002897 | 000 |
| 00721902837944 | K002897 | 000 |
| 00721902837951 | K002897 | 000 |
| 00721902837968 | K002897 | 000 |
| 00721902848193 | K002897 | 000 |
| 00681490909907 | K002897 | 000 |