The following data is part of a premarket notification filed by Heinz Kurz Gmbh Medizintechnik with the FDA for Kurkz K-piston Titanium Stapedial Prosthesis, Model 1006 103-1006 170.
| Device ID | K002221 |
| 510k Number | K002221 |
| Device Name: | KURKZ K-PISTON TITANIUM STAPEDIAL PROSTHESIS, MODEL 1006 103-1006 170 |
| 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-07-24 |
| Decision Date | 2000-08-09 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| EHKM10061701 | K002221 | 000 |
| EHKM10061181 | K002221 | 000 |
| EHKM10061161 | K002221 | 000 |
| EHKM10061141 | K002221 | 000 |
| EHKM10061121 | K002221 | 000 |
| EHKM10061111 | K002221 | 000 |
| EHKM10061101 | K002221 | 000 |
| EHKM10061091 | K002221 | 000 |
| EHKM10061081 | K002221 | 000 |
| EHKM10061071 | K002221 | 000 |
| EHKM10061061 | K002221 | 000 |
| EHKM10061051 | K002221 | 000 |
| EHKM10061041 | K002221 | 000 |
| EHKM10061201 | K002221 | 000 |
| EHKM10061531 | K002221 | 000 |
| EHKM10061681 | K002221 | 000 |
| EHKM10061661 | K002221 | 000 |
| EHKM10061641 | K002221 | 000 |
| EHKM10061621 | K002221 | 000 |
| EHKM10061611 | K002221 | 000 |
| EHKM10061601 | K002221 | 000 |
| EHKM10061591 | K002221 | 000 |
| EHKM10061581 | K002221 | 000 |
| EHKM10061571 | K002221 | 000 |
| EHKM10061561 | K002221 | 000 |
| EHKM10061551 | K002221 | 000 |
| EHKM10061541 | K002221 | 000 |
| EHKM10061031 | K002221 | 000 |