The following data is part of a premarket notification filed by Gyrus Ent L.l.c. with the FDA for Richards Total/partial Prosthesis.
| Device ID | K962564 |
| 510k Number | K962564 |
| Device Name: | RICHARDS TOTAL/PARTIAL PROSTHESIS |
| Classification | Prosthesis, Partial Ossicular Replacement |
| Applicant | GYRUS ENT L.L.C. 2925 APPLING RD. Bartlett, TN 38133 |
| Contact | Ronald K Smith |
| Correspondent | Ronald K Smith GYRUS ENT L.L.C. 2925 APPLING RD. Bartlett, TN 38133 |
| Product Code | ETB |
| CFR Regulation Number | 874.3450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-07-01 |
| Decision Date | 1997-01-22 |
| Summary: | summary |