K000533 is an FDA 510(k) clearance for the VOCOM IMPLANT- 8MM. 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 March 1, 2000, 13 days after receiving the submission on February 17, 2000.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.3620.
| 510(k) Number | K000533 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 17, 2000 |
| Decision Date | March 01, 2000 |
| Days to Decision | 13 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 |