The following data is part of a premarket notification filed by Heinz Kurz Gmbh Medizintechnik with the FDA for Clip Partial Prosthesis-titanium Dresden, Model 1002 250-257.
| Device ID | K013573 |
| 510k Number | K013573 |
| Device Name: | CLIP PARTIAL PROSTHESIS-TITANIUM DRESDEN, MODEL 1002 250-257 |
| Classification | Prosthesis, Partial Ossicular Replacement |
| Applicant | HEINZ KURZ GMBH MEDIZINTECHNIK AMSTEL 320-I Amsterdam, NL 1017 Ap |
| Contact | Dagmar S Maser |
| Correspondent | Dagmar S Maser HEINZ KURZ GMBH MEDIZINTECHNIK AMSTEL 320-I Amsterdam, NL 1017 Ap |
| Product Code | ETB |
| CFR Regulation Number | 874.3450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-10-29 |
| Decision Date | 2001-11-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| EHKM10026171 | K013573 | 000 |
| EHKM10022511 | K013573 | 000 |
| EHKM10022501 | K013573 | 000 |
| EHKM10023681 | K013573 | 000 |
| EHKM10023661 | K013573 | 000 |
| EHKM10023641 | K013573 | 000 |
| EHKM10022741 | K013573 | 000 |
| EHKM10022731 | K013573 | 000 |
| EHKM10022721 | K013573 | 000 |
| EHKM10022701 | K013573 | 000 |
| EHKM10022681 | K013573 | 000 |
| EHKM10022661 | K013573 | 000 |
| EHKM10022641 | K013573 | 000 |
| EHKM10022521 | K013573 | 000 |
| EHKM10022531 | K013573 | 000 |
| EHKM10022541 | K013573 | 000 |
| EHKM10026151 | K013573 | 000 |
| EHKM10023571 | K013573 | 000 |
| EHKM10023561 | K013573 | 000 |
| EHKM10023551 | K013573 | 000 |
| EHKM10023541 | K013573 | 000 |
| EHKM10023531 | K013573 | 000 |
| EHKM10023521 | K013573 | 000 |
| EHKM10023511 | K013573 | 000 |
| EHKM10023501 | K013573 | 000 |
| EHKM10022571 | K013573 | 000 |
| EHKM10022561 | K013573 | 000 |
| EHKM10022551 | K013573 | 000 |
| EHKM10022601 | K013573 | 000 |