Device Classification Name |
mesh, surgical, synthetic, urogynecologic, for apical vaginal and uterine prolapse, transabdominally placed
|
510(k) Number |
K150016 |
Device Name |
Vertessa Lite |
Applicant |
CALDERA MEDICAL, INC. |
5171 CLARETON DRIVE |
AGOURA HILLS,
CA
91301
|
|
Applicant Contact |
Vicki Gail |
Correspondent |
CALDERA MEDICAL, INC. |
5171 CLARETON DRIVE |
AGOURA HILLS,
CA
91301
|
|
Correspondent Contact |
Vicki Gail |
Regulation Number | 878.3300
|
Classification Product Code |
|
Date Received | 01/05/2015 |
Decision Date | 04/06/2015 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
Obstetrics/Gynecology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|