K911580 is an FDA 510(k) clearance for the DONALDSON/SHEPARDS DR/COLLAR/SHAH VENT-MINI 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 September 24, 1991, 174 days after receiving the submission on April 3, 1991.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.3880.
| 510(k) Number | K911580 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 03, 1991 |
| Decision Date | September 24, 1991 |
| Days to Decision | 174 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 |