The following data is part of a premarket notification filed by Trebay Medical Corp. with the FDA for Trebay Total Rectangular Head.
| Device ID | K954518 |
| 510k Number | K954518 |
| Device Name: | TREBAY TOTAL RECTANGULAR HEAD |
| Classification | Replacement, Ossicular Prosthesis, Total |
| 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 | ETA |
| CFR Regulation Number | 874.3495 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-09-28 |
| Decision Date | 1995-10-27 |