The following data is part of a premarket notification filed by Heinz Kurz with the FDA for Tubingen Titanium Prosthesis (ttp) Vario, Models Aerial 1004 010 & Bell 1002 010.
| Device ID | K990923 |
| 510k Number | K990923 |
| Device Name: | TUBINGEN TITANIUM PROSTHESIS (TTP) VARIO, MODELS AERIAL 1004 010 & BELL 1002 010 |
| Classification | Prosthesis, Partial Ossicular Replacement |
| Applicant | HEINZ KURZ TUEBINGER STRASSE 3 Dusslingen, DE D-72144 |
| Contact | Dagmar S Maeser |
| Correspondent | Dagmar S Maeser HEINZ KURZ TUEBINGER STRASSE 3 Dusslingen, DE D-72144 |
| Product Code | ETB |
| CFR Regulation Number | 874.3450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-03-19 |
| Decision Date | 1999-03-31 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| EHKM10040201 | K990923 | 000 |
| EHKM10040101 | K990923 | 000 |
| EHKM10020201 | K990923 | 000 |
| EHKM10020101 | K990923 | 000 |