Device Classification Name |
tube, bronchial (w/wo connector)
|
510(k) Number |
K834565 |
Device Name |
ENDOBRONCHIAL TWIN LUMEN TUBE |
Applicant |
PORTEX, INC. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Correspondent |
PORTEX, INC. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Regulation Number | 868.5720
|
Classification Product Code |
|
Date Received | 12/28/1983 |
Decision Date | 01/17/1984 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|