Device Classification Name |
indicator, physical/chemical sterilization process
|
510(k) Number |
K922481 |
Device Name |
BROWNE GA INDICATOR USE IN 2% ACTIV GLUTARALDEHYDE |
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 | 05/26/1992 |
Decision Date | 06/02/1994 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|