The following data is part of a premarket notification filed by Gyrus Ent L.l.c. with the FDA for Cap Porp, Cap Torp.
| Device ID | K000256 |
| 510k Number | K000256 |
| Device Name: | CAP PORP, CAP TORP |
| 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 | 2000-01-28 |
| Decision Date | 2000-02-11 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00821925030657 | K000256 | 000 |