K001466 is an FDA 510(k) clearance for the VOCOM SILICONE SYSTEM. This device is classified as a System, Vocal Cord Medialization (Class II - Special Controls, product code MIX).
Submitted by Smith & Nephew, Inc. (Bartlett, US). The FDA issued a Cleared decision on July 26, 2000, 77 days after receiving the submission on May 10, 2000.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.3620.
| 510(k) Number | K001466 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 10, 2000 |
| Decision Date | July 26, 2000 |
| Days to Decision | 77 days |
| Submission Type | Traditional |
| Review Panel | Ear, Nose, Throat (EN) |
| Summary | Summary PDF |
| Product Code | MIX — System, Vocal Cord Medialization |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 874.3620 |