The following data is part of a premarket notification filed by Heinz Kurz Gmbh Medizintechnik with the FDA for Socket Stapes Piston W/o Loop, Schobel, Schobel-causse.
| Device ID | K992839 |
| 510k Number | K992839 |
| Device Name: | SOCKET STAPES PISTON W/O LOOP, SCHOBEL, SCHOBEL-CAUSSE |
| Classification | Prosthesis, Partial Ossicular Replacement |
| Applicant | HEINZ KURZ GMBH MEDIZINTECHNIK AMSTEL 320-I Amsterdam, NL 1017 Ap |
| Contact | Dagmar S Maeser |
| Correspondent | Dagmar S Maeser 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 | 1999-08-23 |
| Decision Date | 1999-09-16 |
| Summary: | summary |