The following data is part of a premarket notification filed by Gyrus Ent L.l.c. with the FDA for Smith & Nephew Pistons.
| Device ID | K003214 |
| 510k Number | K003214 |
| Device Name: | SMITH & NEPHEW PISTONS |
| Classification | Prosthesis, Partial Ossicular Replacement |
| Applicant | GYRUS ENT L.L.C. 2925 APPLING RD. Bartlett, TN 38133 |
| Contact | Jeffrey W Cobb |
| Correspondent | Jeffrey W Cobb 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 | 2000-10-13 |
| Decision Date | 2000-10-31 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00821925024236 | K003214 | 000 |
| 00821925022324 | K003214 | 000 |
| 00821925022096 | K003214 | 000 |
| 00821925021594 | K003214 | 000 |
| 00821925020825 | K003214 | 000 |
| 00821925020818 | K003214 | 000 |
| 00821925020801 | K003214 | 000 |
| 00821925020795 | K003214 | 000 |
| 00821925020788 | K003214 | 000 |
| 00821925020771 | K003214 | 000 |
| 00821925020764 | K003214 | 000 |
| 00821925020566 | K003214 | 000 |
| 00821925020559 | K003214 | 000 |
| 00821925020542 | K003214 | 000 |
| 00821925020535 | K003214 | 000 |
| 00821925020528 | K003214 | 000 |
| 00821925020511 | K003214 | 000 |
| 00821925022331 | K003214 | 000 |
| 00821925022348 | K003214 | 000 |
| 00821925026773 | K003214 | 000 |
| 00821925026766 | K003214 | 000 |
| 00821925026759 | K003214 | 000 |
| 00821925026742 | K003214 | 000 |
| 00821925025851 | K003214 | 000 |
| 00821925025844 | K003214 | 000 |
| 00821925025837 | K003214 | 000 |
| 00821925025820 | K003214 | 000 |
| 00821925025721 | K003214 | 000 |
| 00821925025714 | K003214 | 000 |
| 00821925025707 | K003214 | 000 |
| 00821925024212 | K003214 | 000 |
| 00821925023697 | K003214 | 000 |
| 00821925023642 | K003214 | 000 |
| 00821925023611 | K003214 | 000 |
| 00821925023604 | K003214 | 000 |
| 00821925020504 | K003214 | 000 |