Device Classification Name |
mesh, surgical, collagen, staple line reinforcement
|
510(k) Number |
K022044 |
Device Name |
SURGISIS STAPLE LINE REINFORCEMENT |
Applicant |
COOK BIOTECH, INC. |
3055 KENT AVE. |
WEST LAFAYETTE,
IN
47906 -1076
|
|
Applicant Contact |
MARK BLEYER |
Correspondent |
COOK BIOTECH, INC. |
3055 KENT AVE. |
WEST LAFAYETTE,
IN
47906 -1076
|
|
Correspondent Contact |
MARK BLEYER |
Regulation Number | 878.3300
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 06/24/2002 |
Decision Date | 08/23/2002 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|