K011554 is an FDA 510(k) clearance for the LORENZ LACTOSORB VOCAL MEDIALIZATION IMPLANT. This device is classified as a System, Vocal Cord Medialization (Class II - Special Controls, product code MIX).
Submitted by Biomet, Inc. (Warsaw, US). The FDA issued a Cleared decision on June 26, 2001, 39 days after receiving the submission on May 18, 2001.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.3620.
| 510(k) Number | K011554 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 18, 2001 |
| Decision Date | June 26, 2001 |
| Days to Decision | 39 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 |