The following data is part of a premarket notification filed by Trebay Medical Corp. with the FDA for Trebay Partial Rectrangular Heads, Moretz Cam, Incus/stapedial Joint & Straight Incus Strut.
| Device ID | K954517 |
| 510k Number | K954517 |
| Device Name: | TREBAY PARTIAL RECTRANGULAR HEADS, MORETZ CAM, INCUS/STAPEDIAL JOINT & STRAIGHT INCUS STRUT |
| Classification | Prosthesis, Partial Ossicular Replacement |
| Applicant | TREBAY MEDICAL CORP. 4911 CREEKSIDE DR. Clearwater, FL 34620 |
| Contact | Dan H Treace |
| Correspondent | Dan H Treace TREBAY MEDICAL CORP. 4911 CREEKSIDE DR. Clearwater, FL 34620 |
| Product Code | ETB |
| CFR Regulation Number | 874.3450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-09-28 |
| Decision Date | 1995-10-27 |