Device Classification Name |
Mesh, Surgical, Non-Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed
|
510(k) Number |
K130006 |
Device Name |
BIODESIGN SURGISIS ANTERIOR POSTERIOR PELVIC FLOOR GRAFTS |
Applicant |
COOK BIOTECH INCORPORATED |
1425 INNOVATION PLACE |
WEST LAFAYETTE,
IN
47906
|
|
Applicant Contact |
NICK X WANG |
Correspondent |
COOK BIOTECH INCORPORATED |
1425 INNOVATION PLACE |
WEST LAFAYETTE,
IN
47906
|
|
Correspondent Contact |
NICK X WANG |
Regulation Number | 884.5980
|
Classification Product Code |
|
Date Received | 01/02/2013 |
Decision Date | 04/05/2013 |
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
|
|
|