Device Classification Name |
Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector)
|
510(k) Number |
K953483 |
Device Name |
SIMS BLUE LINE ENDOBRONCHIAL TUBE |
Applicant |
SMITHS INDUSTRIES MEDICAL SYSTEMS, INC. |
15 KIT ST. |
KEENE,
NH
03431
|
|
Applicant Contact |
TIMOTHY J TALCOTT |
Correspondent |
SMITHS INDUSTRIES MEDICAL SYSTEMS, INC. |
15 KIT ST. |
KEENE,
NH
03431
|
|
Correspondent Contact |
TIMOTHY J TALCOTT |
Regulation Number | 868.5740
|
Classification Product Code |
|
Date Received | 07/25/1995 |
Decision Date | 10/24/1995 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|