Device Classification Name |
catheter, intravascular, therapeutic, short-term less than 30 days
|
510(k) Number |
K060174 |
Device Name |
SPECTRUM FIVE LUMEN CENTRAL VENOUS CATHETER SET, MODEL C-UQLM10.0-ABRM |
Applicant |
COOK, INC. |
750 DANIELS WAY |
BLOOMINGTON,
IN
47404
|
|
Applicant Contact |
EVANGELINE D LOH |
Correspondent |
COOK, INC. |
750 DANIELS WAY |
BLOOMINGTON,
IN
47404
|
|
Correspondent Contact |
EVANGELINE D LOH |
Regulation Number | 880.5200
|
Classification Product Code |
|
Date Received | 01/23/2006 |
Decision Date | 02/17/2006 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
Yes
|
|
|