The following data is part of a premarket notification filed by Heinz Kurz Gmbh Medizintechnik with the FDA for Clip Piston Awengen, Model# 1006 805 - 1006 861.
| Device ID | K021479 |
| 510k Number | K021479 |
| Device Name: | CLIP PISTON AWENGEN, MODEL# 1006 805 - 1006 861 |
| Classification | Prosthesis, Partial Ossicular Replacement |
| 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 | ETB |
| CFR Regulation Number | 874.3450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-05-08 |
| Decision Date | 2002-05-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| EHKM10068611 | K021479 | 000 |
| EHKM10062591 | K021479 | 000 |
| EHKM10062581 | K021479 | 000 |
| EHKM10062571 | K021479 | 000 |
| EHKM10062561 | K021479 | 000 |
| EHKM10062551 | K021479 | 000 |
| EHKM10062541 | K021479 | 000 |
| EHKM10062531 | K021479 | 000 |
| EHKM10062111 | K021479 | 000 |
| EHKM10062091 | K021479 | 000 |
| EHKM10062081 | K021479 | 000 |
| EHKM10062071 | K021479 | 000 |
| EHKM10062061 | K021479 | 000 |
| EHKM10062051 | K021479 | 000 |
| EHKM10062041 | K021479 | 000 |
| EHKM10062611 | K021479 | 000 |
| EHKM10068031 | K021479 | 000 |
| EHKM10068591 | K021479 | 000 |
| EHKM10068581 | K021479 | 000 |
| EHKM10068571 | K021479 | 000 |
| EHKM10068561 | K021479 | 000 |
| EHKM10068551 | K021479 | 000 |
| EHKM10068541 | K021479 | 000 |
| EHKM10068531 | K021479 | 000 |
| EHKM10068111 | K021479 | 000 |
| EHKM10068091 | K021479 | 000 |
| EHKM10068081 | K021479 | 000 |
| EHKM10068071 | K021479 | 000 |
| EHKM10068061 | K021479 | 000 |
| EHKM10068051 | K021479 | 000 |
| EHKM10068041 | K021479 | 000 |
| EHKM10062031 | K021479 | 000 |