Device Classification Name |
Mesh, Surgical
|
510(k) Number |
K070738 |
Device Name |
SIS FACIAL CYLINDER, SIS FACIAL IMPLANT |
Applicant |
COOK BIOTECH, INC. |
1425 INNOVATION PLACE |
WEST LAFAYETTE,
IN
47906 -1000
|
|
Applicant Contact |
MARY A FADERAN |
Correspondent |
COOK BIOTECH, INC. |
1425 INNOVATION PLACE |
WEST LAFAYETTE,
IN
47906 -1000
|
|
Correspondent Contact |
MARY A FADERAN |
Regulation Number | 878.3300
|
Classification Product Code |
|
Date Received | 03/16/2007 |
Decision Date | 04/05/2007 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Statement |
Statement
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|