Device Classification Name |
Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Female, Mini-Sling
|
510(k) Number |
K110420 |
Device Name |
OPHIRA MINI SLING SYSTEM |
Applicant |
PROMEDON S.A. |
221 ELLIS PARKWAY |
PISCATAWAY,
NJ
08854
|
|
Applicant Contact |
STEPHANIE RAIS |
Correspondent |
PROMEDON S.A. |
221 ELLIS PARKWAY |
PISCATAWAY,
NJ
08854
|
|
Correspondent Contact |
STEPHANIE RAIS |
Regulation Number | 878.3300
|
Classification Product Code |
|
Date Received | 02/14/2011 |
Decision Date | 05/08/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
Gastroenterology/Urology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|