The following data is part of a premarket notification filed by Smith & Nephew, Inc. with the FDA for Vocom Silicone System.
Device ID | K001466 |
510k Number | K001466 |
Device Name: | VOCOM SILICONE SYSTEM |
Classification | System, Vocal Cord Medialization |
Applicant | SMITH & NEPHEW, INC. 2925 APPLING RD. Bartlett, TN 38133 |
Contact | Alicia E Farage |
Correspondent | Alicia E 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 | 2000-05-10 |
Decision Date | 2000-07-26 |