The following data is part of a premarket notification filed by Board Of Directors, Albert Browne Ltd. with the FDA for Browne Ga Indicator Use In 2% Activ Glutaraldehyde.
| Device ID | K922481 |
| 510k Number | K922481 |
| Device Name: | BROWNE GA INDICATOR USE IN 2% ACTIV GLUTARALDEHYDE |
| Classification | Indicator, Physical/chemical Sterilization Process |
| Applicant | BOARD OF DIRECTORS, ALBERT BROWNE LTD. CHANCERY HOUSE, ABBEY GATE LEICESTER Leics. Le4 Oaa, GB |
| Contact | Copson |
| Correspondent | Copson BOARD OF DIRECTORS, ALBERT BROWNE LTD. CHANCERY HOUSE, ABBEY GATE LEICESTER Leics. Le4 Oaa, GB |
| Product Code | JOJ |
| CFR Regulation Number | 880.2800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-05-26 |
| Decision Date | 1994-06-02 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30705037007862 | K922481 | 000 |
| 30705037007831 | K922481 | 000 |
| 10615375003760 | K922481 | 000 |