Device Classification Name |
tube, tracheal/bronchial, differential ventilation (w/wo connector)
|
510(k) Number |
K021920 |
Device Name |
7.0 FR. ENDOBRONCHIAL BLOCKER |
Applicant |
COOK, INC. |
P.O. BOX 489 |
BLOOMINGTON,
IN
47402 -0489
|
|
Applicant Contact |
APRIL LAVENDER |
Correspondent |
COOK, INC. |
P.O. BOX 489 |
BLOOMINGTON,
IN
47402 -0489
|
|
Correspondent Contact |
APRIL LAVENDER |
Regulation Number | 868.5740
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 06/11/2002 |
Decision Date | 08/14/2002 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|