The following data is part of a premarket notification filed by Heinz Kurz with the FDA for Kurz Angular Piston-titanium Prosthesis, Models 1006 600, 1006 601, 1006 602, 1006 650, 1006 651, 1006 652.
| Device ID | K010442 |
| 510k Number | K010442 |
| Device Name: | KURZ ANGULAR PISTON-TITANIUM PROSTHESIS, MODELS 1006 600, 1006 601, 1006 602, 1006 650, 1006 651, 1006 652 |
| Classification | Prosthesis, Partial Ossicular Replacement |
| Applicant | HEINZ KURZ AMSTEL 320-I Amsterdam 1017ap, NL |
| Contact | Dagmar S Maser |
| Correspondent | Dagmar S Maser HEINZ KURZ AMSTEL 320-I Amsterdam 1017ap, NL |
| Product Code | ETB |
| CFR Regulation Number | 874.3450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-02-14 |
| Decision Date | 2001-03-08 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| EHKM10066521 | K010442 | 000 |
| EHKM10066511 | K010442 | 000 |
| EHKM10066501 | K010442 | 000 |
| EHKM10066021 | K010442 | 000 |
| EHKM10066011 | K010442 | 000 |
| EHKM10066001 | K010442 | 000 |
| EHKM10026121 | K010442 | 000 |
| EHKM10026101 | K010442 | 000 |