The following data is part of a premarket notification filed by Heinz Kurz Gmbh Medizintechnik with the FDA for Kurz Clip Piston Mvp, Model 1006 711-13/0.4 Mm + 1006 761-63/0.6mm.
| Device ID | K042503 |
| 510k Number | K042503 |
| Device Name: | KURZ CLIP PISTON MVP, MODEL 1006 711-13/0.4 MM + 1006 761-63/0.6MM |
| Classification | Replacement, Ossicular Prosthesis, Total |
| Applicant | HEINZ KURZ GMBH MEDIZINTECHNIK AMSTEL 320-I Amsterdam, NL 1017 Ap |
| Contact | Dagmar Maser |
| Correspondent | Dagmar Maser HEINZ KURZ GMBH MEDIZINTECHNIK AMSTEL 320-I Amsterdam, NL 1017 Ap |
| Product Code | ETA |
| CFR Regulation Number | 874.3495 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-09-15 |
| Decision Date | 2004-10-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| EHKM10067641 | K042503 | 000 |
| EHKM10067091 | K042503 | 000 |
| EHKM10067101 | K042503 | 000 |
| EHKM10067111 | K042503 | 000 |
| EHKM10067121 | K042503 | 000 |
| EHKM10067131 | K042503 | 000 |
| EHKM10067141 | K042503 | 000 |
| EHKM10067581 | K042503 | 000 |
| EHKM10067591 | K042503 | 000 |
| EHKM10067601 | K042503 | 000 |
| EHKM10067611 | K042503 | 000 |
| EHKM10067621 | K042503 | 000 |
| EHKM10067631 | K042503 | 000 |
| EHKM10067081 | K042503 | 000 |