The following data is part of a premarket notification filed by Board Of Directors, Albert Browne Ltd. with the FDA for Browne Tst Single Use Bowie Dick Type Test Pack.
| Device ID | K932057 |
| 510k Number | K932057 |
| Device Name: | BROWNE TST SINGLE USE BOWIE DICK TYPE TEST PACK |
| Classification | Indicator, Physical/chemical Sterilization Process |
| Applicant | BOARD OF DIRECTORS, ALBERT BROWNE LTD. CHANCERY HOUSE, ABBEY GATE LEICESTER Leics. Le4 Oaa, GB |
| Contact | Charlton |
| Correspondent | Charlton 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 | 1993-04-28 |
| Decision Date | 1994-08-05 |