Device Classification Name |
device, fixation, tracheal tube
|
510(k) Number |
K882891 |
Device Name |
A.C.I. TRACH TIE |
Applicant |
AUXILIARY CARE, INC. |
P.O. BOX 144757 |
CORAL GABLES,
FL
33114
|
|
Applicant Contact |
CARLOS LOPEZ |
Correspondent |
AUXILIARY CARE, INC. |
P.O. BOX 144757 |
CORAL GABLES,
FL
33114
|
|
Correspondent Contact |
CARLOS LOPEZ |
Regulation Number | 868.5770
|
Classification Product Code |
|
Date Received | 07/11/1988 |
Decision Date | 09/19/1988 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|