Device Classification Name |
tube, tracheostomy (w/wo connector)
|
510(k) Number |
K924193 |
Device Name |
TRACHEOSTOMY CARE SET W/ HYDRO PEROX(AHC-20-54685) |
Applicant |
AMERICAN HEALTHCARE CORP. |
ONE AMERICAN HEALTHCARE PLAZA |
3611 KENNEDY ROAD |
SOUTH PLAINFIELD,
NJ
07080
|
|
Applicant Contact |
RALPH S JARRETT |
Correspondent |
AMERICAN HEALTHCARE CORP. |
ONE AMERICAN HEALTHCARE PLAZA |
3611 KENNEDY ROAD |
SOUTH PLAINFIELD,
NJ
07080
|
|
Correspondent Contact |
RALPH S JARRETT |
Regulation Number | 868.5800
|
Classification Product Code |
|
Date Received | 08/20/1992 |
Decision Date | 06/16/1993 |
Decision |
Substantially Equivalent - Kit With Drugs
(SEKD) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|