K926462 is an FDA 510(k) clearance for the BEL-AIR VENTILATION TUBE. This device is classified as a Tube, Tympanostomy (Class II - Special Controls, product code ETD).
Submitted by Exmoor Plastics , Ltd. (Taunton, GB). The FDA issued a Cleared decision on May 5, 1993, 132 days after receiving the submission on December 24, 1992.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.3880.
| 510(k) Number | K926462 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 24, 1992 |
| Decision Date | May 05, 1993 |
| Days to Decision | 132 days |
| Submission Type | Traditional |
| Review Panel | Ear, Nose, Throat (EN) |
| Summary | Statement |
| Product Code | ETD — Tube, Tympanostomy |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 874.3880 |