Device Classification Name |
Mesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed
|
510(k) Number |
K072951 |
Device Name |
PARIETENE DUO AND QUADRA POLYPROPYLENE MESHES |
Applicant |
SOFRADIM PRODUCTION |
150 GLOVER AVENUE |
NORWALK,
CT
06856
|
|
Applicant Contact |
SHARON ALEXANDER |
Correspondent |
SOFRADIM PRODUCTION |
150 GLOVER AVENUE |
NORWALK,
CT
06856
|
|
Correspondent Contact |
SHARON ALEXANDER |
Regulation Number | 884.5980
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 10/18/2007 |
Decision Date | 12/19/2007 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|