K941407 is an FDA 510(k) clearance for the TYMPANOSTOMY (VENTILATION) TUBE. This device is classified as a Tube, Tympanostomy (Class II - Special Controls, product code ETD).
Submitted by Xomed-Treace, Inc. (Jacksonville, US). The FDA issued a Cleared decision on March 14, 1995, 356 days after receiving the submission on March 23, 1994.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.3880.
| 510(k) Number | K941407 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 23, 1994 |
| Decision Date | March 14, 1995 |
| Days to Decision | 356 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 |