Device Classification Name |
mesh, surgical, synthetic, urogynecologic, for pelvic organ prolapse, transvaginally placed
|
510(k) Number |
K091131 |
Device Name |
PELVIC FLOOR REPAIR SYSTEM |
Applicant |
BOSTONSCIENTIFIC |
100 BOSTON SCIENTIFIC WAY |
MARLBOROUGH,
MA
01752
|
|
Applicant Contact |
MICHELLE BERRY |
Correspondent |
BOSTONSCIENTIFIC |
100 BOSTON SCIENTIFIC WAY |
MARLBOROUGH,
MA
01752
|
|
Correspondent Contact |
MICHELLE BERRY |
Regulation Number | 884.5980
|
Classification Product Code |
|
Date Received | 04/20/2009 |
Decision Date | 05/08/2009 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Summary |
Summary
|
Type |
Abbreviated
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|