Device Classification Name |
tube, tracheal (w/wo connector)
|
510(k) Number |
K050785 |
Device Name |
AMSINO ENDOTRACHEAL TUBE |
Applicant |
AMSINO INTERNATIONAL, INC. |
855 TOWNE CENTER DRIVE |
POMONA,
CA
91767
|
|
Applicant Contact |
CHING CHING SEAH |
Correspondent |
AMSINO INTERNATIONAL, INC. |
855 TOWNE CENTER DRIVE |
POMONA,
CA
91767
|
|
Correspondent Contact |
CHING CHING SEAH |
Regulation Number | 868.5730
|
Classification Product Code |
|
Date Received | 03/28/2005 |
Decision Date | 07/15/2005 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|