Device Classification Name |
Mesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed
|
510(k) Number |
K051503 |
Device Name |
UGYTEX SUAL KNIT MESH |
Applicant |
SOFRADIM PRODUCTION |
5 WHITCOMB AVENUE |
AYER,
MA
01432
|
|
Applicant Contact |
PAMELA PAPINEAU |
Correspondent |
SOFRADIM PRODUCTION |
5 WHITCOMB AVENUE |
AYER,
MA
01432
|
|
Correspondent Contact |
PAMELA PAPINEAU |
Regulation Number | 884.5980
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 06/07/2005 |
Decision Date | 08/05/2005 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|