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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Indicator, Sterilization
510(k) Number K965154
Device Name TST CONTROL INTEGRATOR FOR STEAM AUTOCLAVE
Applicant
ALBERT BROWNE LTD.
49 PLAIN ST.
NORTH ATTLEBORO,  MA  02760
Applicant Contact CYNTHIA J.M. NOLTE, PH.D.
Correspondent
ALBERT BROWNE LTD.
49 PLAIN ST.
NORTH ATTLEBORO,  MA  02760
Correspondent Contact CYNTHIA J.M. NOLTE, PH.D.
Regulation Number880.2800
Classification Product Code
LRT  
Date Received12/23/1996
Decision Date 09/19/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Expedited Review Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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