K131947 is an FDA 510(k) clearance for the PROVOX VEGA PUNCTURE SET. This device is classified as a Prosthesis, Laryngeal (taub) (Class II - Special Controls, product code EWL).
Submitted by Atos Medical AB (Horby, SE). The FDA issued a Cleared decision on October 18, 2013, 113 days after receiving the submission on June 27, 2013.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.3730.
| 510(k) Number | K131947 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 27, 2013 |
| Decision Date | October 18, 2013 |
| Days to Decision | 113 days |
| Submission Type | Traditional |
| Review Panel | Ear, Nose, Throat (EN) |
| Summary | Summary PDF |
| Product Code | EWL — Prosthesis, Laryngeal (taub) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 874.3730 |