Device Classification Name |
mesh, surgical, synthetic, urogynecologic, for apical vaginal and uterine prolapse, transabdominally placed
|
510(k) Number |
K112322 |
Device Name |
RESTORELLE POLYPROPYLENE Y MESH |
Applicant |
COLOPLAST A/S |
1601 WEST RIVER ROAD N |
MINNEAPOLIS,
MN
55411
|
|
Applicant Contact |
TIM CRABTREE |
Correspondent |
COLOPLAST A/S |
1601 WEST RIVER ROAD N |
MINNEAPOLIS,
MN
55411
|
|
Correspondent Contact |
TIM CRABTREE |
Regulation Number | 878.3300
|
Classification Product Code |
|
Date Received | 08/12/2011 |
Decision Date | 05/17/2012 |
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
|
|
|