Device Classification Name |
Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector)
|
510(k) Number |
K961977 |
Device Name |
KENDALL SHER-I-BRONCH ENDOBROCHIAL TUBE |
Applicant |
KENDALL HEALTHCARE PRODUCTS CO. DIV.OF TYCO HEALTH |
15 HAMPSHIRE ST. |
MANSFIELD,
MA
02048
|
|
Applicant Contact |
DAVID A OLSON |
Correspondent |
KENDALL HEALTHCARE PRODUCTS CO. DIV.OF TYCO HEALTH |
15 HAMPSHIRE ST. |
MANSFIELD,
MA
02048
|
|
Correspondent Contact |
DAVID A OLSON |
Regulation Number | 868.5740
|
Classification Product Code |
|
Date Received | 05/20/1996 |
Decision Date | 07/31/1996 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|