The following data is part of a premarket notification filed by Silhouette Lift, Inc. with the FDA for Silhouette Instalift.
Device ID | K142061 |
510k Number | K142061 |
Device Name: | SILHOUETTE INSTALIFT |
Classification | Suture, Absorbable, Synthetic, Polyglycolic Acid |
Applicant | SILHOUETTE LIFT, INC. 1 Technology Drive Suite F211 Irvine, CA 92618 |
Contact | Juan Carlos Serna |
Correspondent | Juan Carlos Serna Health Policy Associates, Inc. 690 Canton Street, Suite 302 Westwood, MA 02090 |
Product Code | GAM |
CFR Regulation Number | 878.4493 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2014-07-30 |
Decision Date | 2015-04-24 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
05060033040164 | K142061 | 000 |
05060033040140 | K142061 | 000 |
05060033040102 | K142061 | 000 |
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 |