The following data is part of a premarket notification filed by Smith & Nephew, Inc. with the FDA for Vocom Implant- 8mm.
| Device ID | K000533 |
| 510k Number | K000533 |
| Device Name: | VOCOM IMPLANT- 8MM |
| Classification | System, Vocal Cord Medialization |
| Applicant | SMITH & NEPHEW, INC. 2925 APPLING RD. Bartlett, TN 38133 |
| Contact | Alicia Farage |
| Correspondent | Alicia Farage SMITH & NEPHEW, INC. 2925 APPLING RD. Bartlett, TN 38133 |
| Product Code | MIX |
| CFR Regulation Number | 874.3620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-02-17 |
| Decision Date | 2000-03-01 |