The following data is part of a premarket notification filed by Gyrus Ent L.l.c. with the FDA for Smith & Nephew Off-centered Porp.
| Device ID | K002464 |
| 510k Number | K002464 |
| Device Name: | SMITH & NEPHEW OFF-CENTERED PORP |
| Classification | Prosthesis, Partial Ossicular Replacement |
| 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 | ETB |
| CFR Regulation Number | 874.3450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-08-10 |
| Decision Date | 2000-08-29 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00821925024601 | K002464 | 000 |