Device Classification Name |
Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Female, Mini-Sling
|
510(k) Number |
K121562 |
Device Name |
ALTIS SINGLE INCISION CLING SYSTEM |
Applicant |
COLOPLAST A/S |
1601 WEST RIVER ROAD NORTH |
MINNEAPOLIS,
MN
55411
|
|
Applicant Contact |
JANELL A COLLEY |
Correspondent |
COLOPLAST A/S |
1601 WEST RIVER ROAD NORTH |
MINNEAPOLIS,
MN
55411
|
|
Correspondent Contact |
JANELL A COLLEY |
Regulation Number | 878.3300
|
Classification Product Code |
|
Date Received | 05/29/2012 |
Decision Date | 11/05/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
Gastroenterology/Urology
|
Summary |
Summary
|
Type |
Traditional
|
Clinical Trials |
NCT01272284
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|