Device Classification Name |
Tube Tracheostomy And Tube Cuff
|
510(k) Number |
K921733 |
Device Name |
TRACHEOSTOMY CARE TRAY |
Applicant |
MEDIKMARK, INC. |
333 WEST WACKER DR. |
SUITE 2600 |
CHICAGO,
IL
60606
|
|
Applicant Contact |
RICHARD O WOOD |
Correspondent |
MEDIKMARK, INC. |
333 WEST WACKER DR. |
SUITE 2600 |
CHICAGO,
IL
60606
|
|
Correspondent Contact |
RICHARD O WOOD |
Regulation Number | 868.5800
|
Classification Product Code |
|
Date Received | 04/10/1992 |
Decision Date | 06/15/1994 |
Decision |
Substantially Equivalent - Kit
(SESK) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|