| Device Classification Name |
Disinfectant, Medical Devices
|
| 510(k) Number |
K951162 |
| Device Name |
PHENO-CEN GERMICIDAL DETERGENT |
| Applicant |
| Central Solutions, Inc. |
| 3130 Brinkerhoff Rd. |
|
Kansas City,
KS
66115
|
|
| Applicant Contact |
GARY W HELTON |
| Correspondent |
| Central Solutions, Inc. |
| 3130 Brinkerhoff Rd. |
|
Kansas City,
KS
66115
|
|
| Correspondent Contact |
GARY W HELTON |
| Regulation Number | 880.6890 |
| Classification Product Code |
|
| Date Received | 03/14/1995 |
| Decision Date | 07/11/1995 |
| 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
|
|
|