The following data is part of a premarket notification filed by Silhouette Lift Inc. with the FDA for Silhouette Featherlift / Silhouette Lift.
Device ID | K191299 |
510k Number | K191299 |
Device Name: | Silhouette Featherlift / Silhouette Lift |
Classification | Suture, Nonabsorbable, Synthetic, Polypropylene |
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 | GAW |
CFR Regulation Number | 878.5010 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2019-05-14 |
Decision Date | 2019-06-14 |