Device Classification Name |
mesh, surgical, synthetic, urogynecologic, for stress urinary incontinence, retropubic or transobturator
|
510(k) Number |
K121754 |
FOIA Releasable 510(k) |
K121754
|
Device Name |
BLUE SUI SLING |
Applicant |
BOSTON SCIENTIFIC CORP. |
100 BOSTON SCIENTIFIC WAY |
M21 |
MARLBOROUGH,
MA
01752
|
|
Applicant Contact |
JANET A MCGRATH |
Correspondent |
BOSTON SCIENTIFIC CORP. |
100 BOSTON SCIENTIFIC WAY |
M21 |
MARLBOROUGH,
MA
01752
|
|
Correspondent Contact |
JANET A MCGRATH |
Regulation Number | 878.3300
|
Classification Product Code |
|
Date Received | 06/14/2012 |
Decision Date | 10/10/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
Gastroenterology/Urology
|
Summary |
Summary
|
FDA Review |
Decision Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|