Device Classification Name |
Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed
|
510(k) Number |
K051245 |
Device Name |
POLYFORM SYNTHETIC MESH |
Applicant |
PROXY BIOMEDICAL LTD. |
P.O. BOX 560 |
STILLWATER,
MN
55082
|
|
Applicant Contact |
ELAINE DUNCAN |
Correspondent |
PROXY BIOMEDICAL LTD. |
P.O. BOX 560 |
STILLWATER,
MN
55082
|
|
Correspondent Contact |
ELAINE DUNCAN |
Regulation Number | 878.3300
|
Classification Product Code |
|
Date Received | 05/16/2005 |
Decision Date | 06/17/2005 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
Obstetrics/Gynecology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|