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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Indicator, Physical/Chemical Sterilization Process
510(k) Number K932057
Device Name BROWNE TST SINGLE USE BOWIE DICK TYPE TEST PACK
Applicant
Board of Directors, Albert Browne , Ltd.
Chancery House, Abbey Gate
Leicester
Leics. Le4 Oaa,  GB
Applicant Contact CHARLTON
Correspondent
Board of Directors, Albert Browne , Ltd.
Chancery House, Abbey Gate
Leicester
Leics. Le4 Oaa,  GB
Correspondent Contact CHARLTON
Regulation Number880.2800
Classification Product Code
JOJ  
Date Received04/28/1993
Decision Date 08/05/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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