K954795 is an FDA 510(k) clearance for the AT2 & DOYLE STYLE (C-FLEX) VENT TUBES. This device is classified as a Tube, Tympanostomy (Class II - Special Controls, product code ETD).
Submitted by Trebay Medical Corp. (Clearwater, US). The FDA issued a Cleared decision on November 15, 1995, 28 days after receiving the submission on October 18, 1995.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.3880.
| 510(k) Number | K954795 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 18, 1995 |
| Decision Date | November 15, 1995 |
| Days to Decision | 28 days |
| Submission Type | Traditional |
| Review Panel | Ear, Nose, Throat (EN) |
| Summary | Summary PDF |
| Product Code | ETD — Tube, Tympanostomy |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 874.3880 |