The following data is part of a premarket notification filed by Heinz Kurz with the FDA for Bell Prosthesis (partial).
| Device ID | K972492 |
| 510k Number | K972492 |
| Device Name: | BELL PROSTHESIS (PARTIAL) |
| Classification | Prosthesis, Partial Ossicular Replacement |
| Applicant | HEINZ KURZ TUEBINGER STRASSE 3 Dusslingen, DE D-72144 |
| Contact | Dagmar S Maser |
| Correspondent | Dagmar S Maser HEINZ KURZ TUEBINGER STRASSE 3 Dusslingen, DE D-72144 |
| Product Code | ETB |
| CFR Regulation Number | 874.3450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-07-02 |
| Decision Date | 1997-08-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| EHKM10024301 | K972492 | 000 |
| EHKM10022241 | K972492 | 000 |
| EHKM10022231 | K972492 | 000 |
| EHKM10020331 | K972492 | 000 |
| EHKM10020321 | K972492 | 000 |
| EHKM10020301 | K972492 | 000 |
| EHKM10020291 | K972492 | 000 |
| EHKM10020281 | K972492 | 000 |
| EHKM10020271 | K972492 | 000 |
| EHKM10020261 | K972492 | 000 |
| EHKM10020251 | K972492 | 000 |
| EHKM10020241 | K972492 | 000 |
| EHKM10022251 | K972492 | 000 |
| EHKM10022261 | K972492 | 000 |
| EHKM10024291 | K972492 | 000 |
| EHKM10024281 | K972492 | 000 |
| EHKM10024271 | K972492 | 000 |
| EHKM10024261 | K972492 | 000 |
| EHKM10024251 | K972492 | 000 |
| EHKM10024241 | K972492 | 000 |
| EHKM10024231 | K972492 | 000 |
| EHKM10022301 | K972492 | 000 |
| EHKM10022291 | K972492 | 000 |
| EHKM10022281 | K972492 | 000 |
| EHKM10022271 | K972492 | 000 |
| EHKM10020231 | K972492 | 000 |