Device Classification Name |
Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed
|
510(k) Number |
K122440 |
Device Name |
RESTORELLE L |
Applicant |
COLOPLAST CORP. |
1601 WEST RIVER RD NORTH |
MINNEAPOLIS,
MN
55411
|
|
Applicant Contact |
TIM CRABTREE |
Correspondent |
COLOPLAST CORP. |
1601 WEST RIVER RD NORTH |
MINNEAPOLIS,
MN
55411
|
|
Correspondent Contact |
TIM CRABTREE |
Regulation Number | 878.3300
|
Classification Product Code |
|
Date Received | 08/10/2012 |
Decision Date | 11/19/2012 |
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
|
Recalls |
CDRH Recalls
|
|
|