Device Classification Name |
filter, intravascular, cardiovascular
|
510(k) Number |
K032426 |
Device Name |
GUNHTER TULIP VENA CAVA MREYE FILTER AND RETRIEVAL SET |
Applicant |
COOK, INC. |
750 DANIELS WAY |
P.O. BOX 489 |
BLOOMINGTON,
IN
47402 -0489
|
|
Applicant Contact |
JENNIFER J BOSLEY |
Correspondent |
COOK, INC. |
750 DANIELS WAY |
P.O. BOX 489 |
BLOOMINGTON,
IN
47402 -0489
|
|
Correspondent Contact |
JENNIFER J BOSLEY |
Regulation Number | 870.3375
|
Classification Product Code |
|
Date Received | 08/06/2003 |
Decision Date | 10/31/2003 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|