Device Classification Name |
Device, Fixation, Tracheal Tube
|
510(k) Number |
K140097 |
Device Name |
AMT ENDOTRACHEAL TUBE BRIDLE RETENTION SYSTEM |
Applicant |
APPLIED MEDICAL TECHNOLOGY, INC. |
8000 KATHERINE BOULEVARD |
BRECKSVILLE,
OH
44141
|
|
Applicant Contact |
JOSHUA MEINKE |
Correspondent |
APPLIED MEDICAL TECHNOLOGY, INC. |
8000 KATHERINE BOULEVARD |
BRECKSVILLE,
OH
44141
|
|
Correspondent Contact |
JOSHUA MEINKE |
Regulation Number | 868.5770
|
Classification Product Code |
|
Date Received | 01/14/2014 |
Decision Date | 09/24/2014 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|