The following data is part of a premarket notification filed by Gyrus Ent L.l.c. with the FDA for Bojrab Universal Long Imlant, Model Tbd.
| Device ID | K001902 |
| 510k Number | K001902 |
| Device Name: | BOJRAB UNIVERSAL LONG IMLANT, MODEL TBD |
| Classification | Replacement, Ossicular Prosthesis, Total |
| Applicant | GYRUS ENT L.L.C. 2925 APPLING RD. Bartlett, TN 38133 |
| Contact | Alicia Farage |
| Correspondent | Alicia Farage GYRUS ENT L.L.C. 2925 APPLING RD. Bartlett, TN 38133 |
| Product Code | ETA |
| CFR Regulation Number | 874.3495 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-06-22 |
| Decision Date | 2000-07-10 |