Device Classification Name |
catheter, intravascular, therapeutic, short-term less than 30 days
|
510(k) Number |
K950118 |
Device Name |
ABRM CATHETER |
Applicant |
COOK, INC. |
925 SOUTH CURRY PIKE |
P.O. BOX 489 |
BLOOMINGTON,
IN
47402
|
|
Applicant Contact |
APRIL LAVENDER |
Correspondent |
COOK, INC. |
925 SOUTH CURRY PIKE |
P.O. BOX 489 |
BLOOMINGTON,
IN
47402
|
|
Correspondent Contact |
APRIL LAVENDER |
Regulation Number | 880.5200
|
Classification Product Code |
|
Date Received | 01/11/1995 |
Decision Date | 02/08/1996 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|