Device Classification Name |
suture, absorbable, synthetic, polyglycolic acid
|
510(k) Number |
K142061 |
Device Name |
SILHOUETTE INSTALIFT |
Applicant |
SILHOUETTE LIFT, INC. |
1 Technology Drive |
Suite F211 |
irvine,
CA
92618
|
|
Applicant Contact |
juan carlos serna |
Correspondent |
Health Policy Associates, Inc. |
690 Canton Street, Suite 302 |
westwood,
MA
02090
|
|
Correspondent Contact |
juan carlos serna |
Regulation Number | 878.4493
|
Classification Product Code |
|
Date Received | 07/30/2014 |
Decision Date | 04/24/2015 |
Decision |
substantially equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
statement |
statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|