| Device Classification Name |
Disinfectant, Medical Devices
|
| 510(k) Number |
K964828 |
| Device Name |
VIREX II 128 GERMICIDAL CLEANER AND DEODORANT |
| Applicant |
| S.C. Johnson & Son, Inc. |
| 1525 Howe St. |
|
Racine,
WI
53403
|
|
| Applicant Contact |
ROBERT B O'BRIEN |
| Correspondent |
| S.C. Johnson & Son, Inc. |
| 1525 Howe St. |
|
Racine,
WI
53403
|
|
| Correspondent Contact |
ROBERT B O'BRIEN |
| Regulation Number | 880.6890 |
| Classification Product Code |
|
| Date Received | 12/02/1996 |
| Decision Date | 12/19/1996 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
General Hospital
|
| 510k Review Panel |
General Hospital
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|