The following data is part of a premarket notification filed by Heinz Kurz with the FDA for K-piston With Band Hook /angular Piston.
| Device ID | K973356 |
| 510k Number | K973356 |
| Device Name: | K-PISTON WITH BAND HOOK /ANGULAR PISTON |
| Classification | Prosthesis, Partial Ossicular Replacement |
| Applicant | HEINZ KURZ TUEBINGER STRASSE 3 Dusslingen, DE D-72144 |
| Contact | Dagmar S Maser |
| Correspondent | Dagmar S Maser HEINZ KURZ TUEBINGER STRASSE 3 Dusslingen, DE D-72144 |
| Product Code | ETB |
| CFR Regulation Number | 874.3450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-09-08 |
| Decision Date | 1997-11-21 |
| Summary: | summary |