The following data is part of a premarket notification filed by River Medical, Inc. with the FDA for H/a Total-regular, H/a Total-offset.
| Device ID | K913286 |
| 510k Number | K913286 |
| Device Name: | H/A TOTAL-REGULAR, H/A TOTAL-OFFSET |
| Classification | Replacement, Ossicular Prosthesis, Total |
| Applicant | RIVER MEDICAL, INC. P.O.BOX 30517 Memphis, TN 38130 |
| Contact | George W Murray |
| Correspondent | George W Murray RIVER MEDICAL, INC. P.O.BOX 30517 Memphis, TN 38130 |
| Product Code | ETA |
| CFR Regulation Number | 874.3495 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-07-24 |
| Decision Date | 1991-12-18 |