Device Classification Name |
tube, tracheal (w/wo connector)
|
510(k) Number |
K031794 |
Device Name |
ENDOFLEX TRACHEAL TUBE |
Applicant |
MERLYN ASSOCIATES INC. |
AMSINO INTERNATIONAL INC. |
4501 BRICKELL PRIVADO |
ONTARIO,
CA
91761
|
|
Applicant Contact |
CHING CHING SEAH, PH.D. |
Correspondent |
MERLYN ASSOCIATES INC. |
AMSINO INTERNATIONAL INC. |
4501 BRICKELL PRIVADO |
ONTARIO,
CA
91761
|
|
Correspondent Contact |
CHING CHING SEAH, PH.D. |
Regulation Number | 868.5730
|
Classification Product Code |
|
Date Received | 06/10/2003 |
Decision Date | 03/12/2004 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|