The following data is part of a premarket notification filed by Silhouette Lift Inc. with the FDA for Silhouette Instalift.
Device ID | K200140 |
510k Number | K200140 |
Device Name: | Silhouette Instalift |
Classification | Suture, Absorbable, Synthetic, Polyglycolic Acid |
Applicant | Silhouette Lift Inc. 1 Technology Drive F211 Irvine, CA 92618 |
Contact | Anthony Dibernardo |
Correspondent | Anthony Dibernardo Silhouette Lift Inc. 1 Technology Drive F211 Irvine, CA 92618 |
Product Code | GAM |
CFR Regulation Number | 878.4493 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2020-01-21 |
Decision Date | 2020-03-27 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
SILHOUETTE INSTALIFT 87019765 5950448 Live/Registered |
Sinclair Pharmaceuticals Limited 2016-04-29 |
SILHOUETTE INSTALIFT 86373714 5166796 Live/Registered |
Sinclair Pharmaceuticals Limited 2014-08-21 |