The following data is part of a premarket notification filed by Gyrus Ent L.l.c. with the FDA for Pc Coated Fluoroplastic Vent Tubes.
| Device ID | K000801 |
| 510k Number | K000801 |
| Device Name: | PC COATED FLUOROPLASTIC VENT TUBES |
| Classification | Tube, Tympanostomy |
| 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 | ETD |
| CFR Regulation Number | 874.3880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-03-13 |
| Decision Date | 2000-06-19 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00821925039698 | K000801 | 000 |
| 00821925034525 | K000801 | 000 |
| 00821925024755 | K000801 | 000 |
| 00821925024748 | K000801 | 000 |
| 00821925020429 | K000801 | 000 |
| 00821925020399 | K000801 | 000 |
| 00821925034174 | K000801 | 000 |
| 00821925020405 | K000801 | 000 |
| 00821925024663 | K000801 | 000 |
| 00821925024632 | K000801 | 000 |
| 00821925020269 | K000801 | 000 |
| 00821925020238 | K000801 | 000 |
| 00821925020252 | K000801 | 000 |
| 00821925020207 | K000801 | 000 |
| 00821925020221 | K000801 | 000 |
| 00821925028500 | K000801 | 000 |
| 00821925028517 | K000801 | 000 |
| 00821925024106 | K000801 | 000 |
| 00821925024724 | K000801 | 000 |
| 00821925020573 | K000801 | 000 |
| 00821925025448 | K000801 | 000 |
| 00821925025431 | K000801 | 000 |
| 00821925022812 | K000801 | 000 |
| 00821925039247 | K000801 | 000 |
| 00821925039230 | K000801 | 000 |
| 00821925020597 | K000801 | 000 |
| 00821925039162 | K000801 | 000 |
| 00821925024946 | K000801 | 000 |
| 00821925024939 | K000801 | 000 |
| 00821925039131 | K000801 | 000 |
| 00821925024717 | K000801 | 000 |
| 00821925024700 | K000801 | 000 |
| 00821925039070 | K000801 | 000 |
| 00821925021488 | K000801 | 000 |
| 00821925021440 | K000801 | 000 |
| 00821925025424 | K000801 | 000 |
| 00821925020191 | K000801 | 000 |