Device Classification Name |
tube, tracheal/bronchial, differential ventilation (w/wo connector)
|
510(k) Number |
K051522 |
Device Name |
SILBRONCHO DOUBLE LUMEN TUBE |
Applicant |
FUJI SYSTEMS CORP. |
6329 W. WATERVIEW COURT |
MCCORDSVILLE,
IN
46055 -9501
|
|
Applicant Contact |
PAUL E DRYDEN |
Correspondent |
FUJI SYSTEMS CORP. |
6329 W. WATERVIEW COURT |
MCCORDSVILLE,
IN
46055 -9501
|
|
Correspondent Contact |
PAUL E DRYDEN |
Regulation Number | 868.5740
|
Classification Product Code |
|
Date Received | 06/08/2005 |
Decision Date | 08/17/2005 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|