K830228 is an FDA 510(k) clearance for the OTOLOGICAL VENTILATION TUBES-VARIOUS. This device is classified as a Tube, Tympanostomy (Class II - Special Controls, product code ETD).
Submitted by Micromedics, Inc. (Mchenry, US). The FDA issued a Cleared decision on March 7, 1983, 42 days after receiving the submission on January 24, 1983.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.3880.
| 510(k) Number | K830228 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 24, 1983 |
| Decision Date | March 07, 1983 |
| Days to Decision | 42 days |
| Submission Type | Traditional |
| Review Panel | Ear, Nose, Throat (EN) |
| Summary | — |
| Product Code | ETD — Tube, Tympanostomy |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 874.3880 |