K974007 is an FDA 510(k) clearance for the SHAH PERMAVENT. 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 December 12, 1997, 52 days after receiving the submission on October 21, 1997.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.3880.
| 510(k) Number | K974007 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 21, 1997 |
| Decision Date | December 12, 1997 |
| Days to Decision | 52 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 |