The following data is part of a premarket notification filed by Heinz Kurz Gmbh Medizintechnik with the FDA for Aerial Prosthesis, Aerial Prosthesis, Model Dusseldorf, Dresden Aerial Prosthesis, Aerial Prosthesis, Model Tubingen.
| Device ID | K972585 |
| 510k Number | K972585 |
| Device Name: | AERIAL PROSTHESIS, AERIAL PROSTHESIS, MODEL DUSSELDORF, DRESDEN AERIAL PROSTHESIS, AERIAL PROSTHESIS, MODEL TUBINGEN |
| Classification | Replacement, Ossicular Prosthesis, Total |
| Applicant | HEINZ KURZ GMBH MEDIZINTECHNIK TUBINGER STRASSE 3 Dusslingen, DE D-72144 |
| Contact | Dagmar S Maser |
| Correspondent | Dagmar S Maser HEINZ KURZ GMBH MEDIZINTECHNIK TUBINGER STRASSE 3 Dusslingen, DE D-72144 |
| Product Code | ETA |
| CFR Regulation Number | 874.3495 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-07-10 |
| Decision Date | 1997-08-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| EHKM10040341 | K972585 | 000 |
| EHKM10040491 | K972585 | 000 |
| EHKM10042341 | K972585 | 000 |
| EHKM10042351 | K972585 | 000 |
| EHKM10042361 | K972585 | 000 |
| EHKM10042371 | K972585 | 000 |
| EHKM10042381 | K972585 | 000 |
| EHKM10042391 | K972585 | 000 |
| EHKM10042401 | K972585 | 000 |
| EHKM10042411 | K972585 | 000 |
| EHKM10040481 | K972585 | 000 |
| EHKM10040461 | K972585 | 000 |
| EHKM10040441 | K972585 | 000 |
| EHKM10040351 | K972585 | 000 |
| EHKM10040361 | K972585 | 000 |
| EHKM10040371 | K972585 | 000 |
| EHKM10040381 | K972585 | 000 |
| EHKM10040391 | K972585 | 000 |
| EHKM10040401 | K972585 | 000 |
| EHKM10040411 | K972585 | 000 |
| EHKM10040421 | K972585 | 000 |
| EHKM10040431 | K972585 | 000 |
| EHKM10042421 | K972585 | 000 |
| EHKM10042431 | K972585 | 000 |
| EHKM10042441 | K972585 | 000 |
| EHKM10044431 | K972585 | 000 |
| EHKM10044441 | K972585 | 000 |
| EHKM10044461 | K972585 | 000 |
| EHKM10044481 | K972585 | 000 |
| EHKM10044491 | K972585 | 000 |
| EHKM10044581 | K972585 | 000 |
| EHKM10044591 | K972585 | 000 |
| EHKM10044601 | K972585 | 000 |
| EHKM10044611 | K972585 | 000 |
| EHKM10044421 | K972585 | 000 |
| EHKM10044411 | K972585 | 000 |
| EHKM10044401 | K972585 | 000 |
| EHKM10042461 | K972585 | 000 |
| EHKM10042481 | K972585 | 000 |
| EHKM10042491 | K972585 | 000 |
| EHKM10044341 | K972585 | 000 |
| EHKM10044351 | K972585 | 000 |
| EHKM10044361 | K972585 | 000 |
| EHKM10044371 | K972585 | 000 |
| EHKM10044381 | K972585 | 000 |
| EHKM10044391 | K972585 | 000 |
| EHKM10044621 | K972585 | 000 |