Device Classification Name |
Mesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed
|
510(k) Number |
K102815 |
Device Name |
SURELIFT PROLAPSE SYSTEM |
Applicant |
NEOMEDIC INTERNATIONAL |
7307 GLOUCHESTER DRIVE |
EDINA,
MN
55435
|
|
Applicant Contact |
JEFFREY R SHIDEMAN |
Correspondent |
NEOMEDIC INTERNATIONAL |
7307 GLOUCHESTER DRIVE |
EDINA,
MN
55435
|
|
Correspondent Contact |
JEFFREY R SHIDEMAN |
Regulation Number | 884.5980
|
Classification Product Code |
|
Date Received | 09/28/2010 |
Decision Date | 07/07/2011 |
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
|
|
|