| Device Classification Name |
Indicator, Physical/Chemical Sterilization Process
|
| 510(k) Number |
K902958 |
| Device Name |
TST CONTROL INTEGRATOR FOR STEAM AUTOCLAVE |
| Applicant |
| Board of Directors, Albert Browne , Ltd. |
| Chancery House, Abbey Gate |
| Leicester |
|
Leics. Le4 Oaa,
GB
|
|
| Applicant Contact |
COPSON |
| Correspondent |
| Board of Directors, Albert Browne , Ltd. |
| Chancery House, Abbey Gate |
| Leicester |
|
Leics. Le4 Oaa,
GB
|
|
| Correspondent Contact |
COPSON |
| Regulation Number | 880.2800 |
| Classification Product Code |
|
| Date Received | 07/05/1990 |
| Decision Date | 11/01/1990 |
| 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
|
|
|