Device Classification Name |
mesh, surgical, synthetic, urogynecologic, for apical vaginal and uterine prolapse, transabdominally placed
|
510(k) Number |
K123028 |
Device Name |
VERTESSA LITE 10 X20CM, VERTESSA LITE 11 X 30CM, VERTESSA LITE Y-MESH |
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 | 09/28/2012 |
Decision Date | 04/25/2013 |
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
|
|
|