Device Classification Name |
Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector)
|
510(k) Number |
K121462 |
Device Name |
EZ-BLOCKER |
Applicant |
EZ-BLOCKER B.V. |
4655 KIRKWOOD COURT |
BOULDER,
CO
80301
|
|
Applicant Contact |
LEWIS WARD |
Correspondent |
EZ-BLOCKER B.V. |
4655 KIRKWOOD COURT |
BOULDER,
CO
80301
|
|
Correspondent Contact |
LEWIS WARD |
Regulation Number | 868.5740
|
Classification Product Code |
|
Date Received | 05/17/2012 |
Decision Date | 09/28/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|