The following data is part of a premarket notification filed by Treace Medical, Inc. with the FDA for Causse Sponge Boat.
| Device ID | K841353 |
| 510k Number | K841353 |
| Device Name: | CAUSSE SPONGE BOAT |
| Classification | Prosthesis, Partial Ossicular Replacement |
| Applicant | TREACE MEDICAL, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | ETB |
| CFR Regulation Number | 874.3450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-04-02 |
| Decision Date | 1984-07-06 |