K921923 is an FDA 510(k) clearance for the TITANIUM VENTILATION TUBES. 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 February 12, 1993, 310 days after receiving the submission on April 8, 1992.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.3880.
| 510(k) Number | K921923 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 08, 1992 |
| Decision Date | February 12, 1993 |
| Days to Decision | 310 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 |