Device Classification Name |
Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector)
|
510(k) Number |
K897046 |
Device Name |
LASER RESISTANT TRACHEAL TUBE |
Applicant |
SHERIDAN CATHETER CORP. |
ROUTE 40 |
ARGYLE,
NY
12809
|
|
Applicant Contact |
STEEN, PHD |
Correspondent |
SHERIDAN CATHETER CORP. |
ROUTE 40 |
ARGYLE,
NY
12809
|
|
Correspondent Contact |
STEEN, PHD |
Regulation Number | 868.5740
|
Classification Product Code |
|
Date Received | 12/18/1989 |
Decision Date | 03/23/1990 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|