K062385 is an FDA 510(k) clearance for the BLUE PTFE (FLUOROPLASTIC) VENTILATION TUBES. This device is classified as a Tube, Tympanostomy (Class II - Special Controls, product code ETD).
Submitted by Grace Medical, Inc. (Memphis, US). The FDA issued a Cleared decision on September 27, 2006, 43 days after receiving the submission on August 15, 2006.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.3880.
| 510(k) Number | K062385 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 15, 2006 |
| Decision Date | September 27, 2006 |
| Days to Decision | 43 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 |