Device Classification Name |
Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Female, Mini-Sling
|
510(k) Number |
K020652 |
Device Name |
HERNIAMESH T-SLING |
Applicant |
HERNIAMESH |
8 ORANGE DR. |
JERICHO,
NY
11753
|
|
Applicant Contact |
LORENA TRABUCCO |
Correspondent |
HERNIAMESH |
8 ORANGE DR. |
JERICHO,
NY
11753
|
|
Correspondent Contact |
LORENA TRABUCCO |
Regulation Number | 878.3300
|
Classification Product Code |
|
Date Received | 02/28/2002 |
Decision Date | 05/15/2002 |
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
|
|
|