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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 K902958
Device Name TST CONTROL INTEGRATOR FOR STEAM AUTOCLAVE
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 Number880.2800
Classification Product Code
JOJ  
Date Received07/05/1990
Decision Date 11/01/1990
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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