Device Classification Name |
tube, tracheostomy (w/wo connector)
|
510(k) Number |
K870181 |
Device Name |
JOHNSON INTRATRACHEAL OXYGEN CATHETER SET |
Applicant |
COOK, INC. |
925 SOUTH CURRY PIKE |
P.O. BOX 489 |
BLOOMINGTON,
IN
47402
|
|
Applicant Contact |
DEXTER J ELKINS |
Correspondent |
COOK, INC. |
925 SOUTH CURRY PIKE |
P.O. BOX 489 |
BLOOMINGTON,
IN
47402
|
|
Correspondent Contact |
DEXTER J ELKINS |
Regulation Number | 868.5800
|
Classification Product Code |
|
Date Received | 01/15/1987 |
Decision Date | 05/14/1987 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|