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510(k) Data Aggregation
K Number
K971971Device Name
BROWNE TST SINGLE USE BOWIE-DICK TYPE TEST PACK
Manufacturer
BOARD OF DIRECTORS, ALBERT BROWNE LTD.
Date Cleared
1998-07-10
(407 days)
Product Code
JOJ
Regulation Number
880.2800Why did this record match?
Applicant Name (Manufacturer) :
BOARD OF DIRECTORS, ALBERT BROWNE LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Browne TST Single Use Bowie-Dick Type Test Pack is a chemical sterilization process monitor which demonstrates adequate air removal and steam penetration during a 132°C (270°F) or 134°C (273°F) autoclave processing cycle by means of a yellow to blue color change.
Device Description
The Browne TST Single Use Bowie Dick Type Test Pack is a paper sheet containing an indicator figure wrapped in multiple layers of paper which is designed to monitor air removal and steam penetration during a 132 °C (270°F) or 134°C (273°F) steam autoclave processing cycle with a hold time of 3-4 minutes. The device changes color from yellow to blue when air removal during the cycle is sufficient to allow complete, even, steam penetration.
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K Number
K970918Device Name
BROWNE STEAM INDICATOR
Manufacturer
BOARD OF DIRECTORS, ALBERT BROWNE LTD.
Date Cleared
1997-06-24
(104 days)
Product Code
JOJ
Regulation Number
880.2800Why did this record match?
Applicant Name (Manufacturer) :
BOARD OF DIRECTORS, ALBERT BROWNE LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Browne Steam Indicator is a process indicator to be used in a steam autoclave with a working range of 121-134°C to distinguish between processed and unprocessed units.
Device Description
The Browne Steam Indicator is a paper strip with indicator ink pads on each end. The indicator ink pads change color from white to black through a brown intermediate in a steam autoclave working at 121-134°C (250-273°F).
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