Device Classification Name |
Tube, Tracheal (W/Wo Connector)
|
510(k) Number |
K954751 |
Device Name |
SILICONE ENDOTRACHEAL TUBE |
Applicant |
UNOMEDICAL SDN BHD |
P.O. BOX NO. 18 |
SUNGEI PATANI KEDAH |
WEST MALAYSIA,
MY
|
|
Applicant Contact |
PATRICK J LAMB |
Correspondent |
UNOMEDICAL SDN BHD |
P.O. BOX NO. 18 |
SUNGEI PATANI KEDAH |
WEST MALAYSIA,
MY
|
|
Correspondent Contact |
PATRICK J LAMB |
Regulation Number | 868.5730
|
Classification Product Code |
|
Date Received | 10/16/1995 |
Decision Date | 12/08/1995 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|