The following data is part of a premarket notification filed by Gyrus Ent L.l.c. with the FDA for Fluoroplastic Ventilation Tubes.
| Device ID | K992222 |
| 510k Number | K992222 |
| Device Name: | FLUOROPLASTIC VENTILATION TUBES |
| Classification | Tube, Tympanostomy |
| Applicant | GYRUS ENT L.L.C. 2925 APPLING RD. Bartlett, TN 38133 |
| Contact | Alicia E Farage |
| Correspondent | Alicia E Farage GYRUS ENT L.L.C. 2925 APPLING RD. Bartlett, TN 38133 |
| Product Code | ETD |
| CFR Regulation Number | 874.3880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-07-01 |
| Decision Date | 1999-08-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00821925039841 | K992222 | 000 |
| 00821925020634 | K992222 | 000 |
| 00821925020580 | K992222 | 000 |
| 00821925020603 | K992222 | 000 |
| 00821925020641 | K992222 | 000 |
| 00821925033979 | K992222 | 000 |
| 00821925020368 | K992222 | 000 |
| 00821925020351 | K992222 | 000 |
| 00821925020665 | K992222 | 000 |
| 00821925020375 | K992222 | 000 |
| 00821925022676 | K992222 | 000 |
| 00821925023949 | K992222 | 000 |
| 00821925020658 | K992222 | 000 |