The following data is part of a premarket notification filed by Invotec International, Inc. with the FDA for Titanium Ossicular Replacment System.
| Device ID | K030492 |
| 510k Number | K030492 |
| Device Name: | TITANIUM OSSICULAR REPLACMENT SYSTEM |
| Classification | Replacement, Ossicular Prosthesis, Total |
| Applicant | INVOTEC INTERNATIONAL, INC. 6833 PHILLIPS INDUSTRIAL BLVD. Jacksonville, FL 32256 -3029 |
| Contact | Jeffrey L Aull |
| Correspondent | Jeffrey L Aull INVOTEC INTERNATIONAL, INC. 6833 PHILLIPS INDUSTRIAL BLVD. Jacksonville, FL 32256 -3029 |
| Product Code | ETA |
| CFR Regulation Number | 874.3495 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-02-19 |
| Decision Date | 2003-03-03 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04250381805299 | K030492 | 000 |
| 04250381805053 | K030492 | 000 |
| 04250381805039 | K030492 | 000 |
| 04250381804278 | K030492 | 000 |
| 04250381804230 | K030492 | 000 |
| 04250381804179 | K030492 | 000 |
| 04250381804032 | K030492 | 000 |
| 04250381804025 | K030492 | 000 |
| 04250381803943 | K030492 | 000 |
| 04250381803912 | K030492 | 000 |
| 04250381803899 | K030492 | 000 |
| 04250381803882 | K030492 | 000 |
| 04250381803790 | K030492 | 000 |
| 04250381805060 | K030492 | 000 |
| 04250381805077 | K030492 | 000 |
| 04250381805282 | K030492 | 000 |
| 04250381805275 | K030492 | 000 |
| 04250381805251 | K030492 | 000 |
| 04250381805244 | K030492 | 000 |
| 04250381805237 | K030492 | 000 |
| 04250381805206 | K030492 | 000 |
| 04250381804650 | K030492 | 000 |
| 04250381804582 | K030492 | 000 |
| 04250381804261 | K030492 | 000 |
| 04250381805213 | K030492 | 000 |
| 04250381805152 | K030492 | 000 |
| 04250381805084 | K030492 | 000 |
| 04250381803738 | K030492 | 000 |