Device Classification Name |
Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Female, Mini-Sling
|
510(k) Number |
K063136 |
Device Name |
NEEDLELESS SLING |
Applicant |
SPECIALITIES REMEEX INTERNATIONAL, S.L. |
7307 GLOUCHESTER DRIVE |
EDINA,
MN
55435
|
|
Applicant Contact |
JEFFREY R SHIDEMAN |
Correspondent |
SPECIALITIES REMEEX INTERNATIONAL, S.L. |
7307 GLOUCHESTER DRIVE |
EDINA,
MN
55435
|
|
Correspondent Contact |
JEFFREY R SHIDEMAN |
Regulation Number | 878.3300
|
Classification Product Code |
|
Date Received | 10/16/2006 |
Decision Date | 12/19/2006 |
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
|
|
|