The following data is part of a premarket notification filed by Gyrus Ent L.l.c. with the FDA for Smart Offset Stapes Piston; Smart Isj Prosthesis.
| Device ID | K033554 |
| 510k Number | K033554 |
| Device Name: | SMART OFFSET STAPES PISTON; SMART ISJ PROSTHESIS |
| Classification | Prosthesis, Partial Ossicular Replacement |
| Applicant | GYRUS ENT L.L.C. 2925 APPLING RD. Bartlett, TN 38133 |
| Contact | Gregory Sredin |
| Correspondent | Gregory Sredin GYRUS ENT L.L.C. 2925 APPLING RD. Bartlett, TN 38133 |
| Product Code | ETB |
| CFR Regulation Number | 874.3450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-11-12 |
| Decision Date | 2003-11-24 |
| Summary: | summary |