Device Classification Name |
Mesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed
|
510(k) Number |
K081710 |
Device Name |
APOGEE AND PERIGEE SYSTEMS WITH PC COATED INTEPRO LITE |
Applicant |
AMERICAN MEDICAL SYSTEMS |
10700 BREN RD., WEST |
MINNETONKA,
MN
55343
|
|
Applicant Contact |
DENISE THOMPSON |
Correspondent |
AMERICAN MEDICAL SYSTEMS |
10700 BREN RD., WEST |
MINNETONKA,
MN
55343
|
|
Correspondent Contact |
DENISE THOMPSON |
Regulation Number | 884.5980
|
Classification Product Code |
|
Date Received | 06/17/2008 |
Decision Date | 10/15/2008 |
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
|
|
|