The following data is part of a premarket notification filed by Biomet, Inc. with the FDA for Lorenz Lactosorb Vocal Medialization Implant.
| Device ID | K011554 |
| 510k Number | K011554 |
| Device Name: | LORENZ LACTOSORB VOCAL MEDIALIZATION IMPLANT |
| Classification | System, Vocal Cord Medialization |
| Applicant | BIOMET, INC. P.O. BOX 587 AIRPORT INDUSTRIAL PARK Warsaw, IN 46581 -0587 |
| Contact | Patricia Sandborn Beres |
| Correspondent | Patricia Sandborn Beres BIOMET, INC. P.O. BOX 587 AIRPORT INDUSTRIAL PARK Warsaw, IN 46581 -0587 |
| Product Code | MIX |
| CFR Regulation Number | 874.3620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-05-18 |
| Decision Date | 2001-06-26 |