Device Classification Name |
Mesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed
|
510(k) Number |
K053414 |
Device Name |
MENTOR NOVASILK MESH |
Applicant |
MENTOR CORP. |
201 MENTOR DRIVE |
SANTA BARBARA,
CA
93111
|
|
Applicant Contact |
DONNA A CRAWFORD |
Correspondent |
MENTOR CORP. |
201 MENTOR DRIVE |
SANTA BARBARA,
CA
93111
|
|
Correspondent Contact |
DONNA A CRAWFORD |
Regulation Number | 884.5980
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 12/07/2005 |
Decision Date | 12/27/2005 |
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
|
|
|