Device Classification Name |
suture, absorbable, synthetic, polyglycolic acid
|
510(k) Number |
K200140 |
Device Name |
Silhouette Instalift |
Applicant |
Silhouette Lift Inc. |
1 Technology Drive F211 |
Irvine,
CA
92618
|
|
Applicant Contact |
Anthony DiBernardo |
Correspondent |
Silhouette Lift Inc. |
1 Technology Drive F211 |
Irvine,
CA
92618
|
|
Correspondent Contact |
Anthony DiBernardo |
Regulation Number | 878.4493
|
Classification Product Code |
|
Date Received | 01/21/2020 |
Decision Date | 03/27/2020 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|