K960477 is an FDA 510(k) clearance for the VENTILATION TUBES. This device is classified as a Tube, Tympanostomy (Class II - Special Controls, product code ETD).
Submitted by Smith & Nephew, Inc. (Washington, US). The FDA issued a Cleared decision on February 26, 1996, 25 days after receiving the submission on February 1, 1996.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.3880.
| 510(k) Number | K960477 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 01, 1996 |
| Decision Date | February 26, 1996 |
| Days to Decision | 25 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 |