Device Classification Name |
Disinfectant, Medical Devices
|
510(k) Number |
K992661 |
Device Name |
CONTROL III ELITE |
Applicant |
MARIL PRODUCTS, INC. |
320 WEST 6TH ST. |
TUSTIN,
CA
92780
|
|
Applicant Contact |
ANNE R WHITEHAIR |
Correspondent |
MARIL PRODUCTS, INC. |
320 WEST 6TH ST. |
TUSTIN,
CA
92780
|
|
Correspondent Contact |
ANNE R WHITEHAIR |
Regulation Number | 880.6890 |
Classification Product Code |
|
Date Received | 08/09/1999 |
Decision Date | 09/14/1999 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|