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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 K021161
Device Name TSO3 OZONE CHEMICAL INDICATOR
Applicant
TECHNOLOGIES OF STERILIZATION WITH OXONE, TSO3 INC
33 BLACK WATCH TRAIL
FAIRPORT,  NY  14450
Applicant Contact CHARLES O HANCOCK
Correspondent
TECHNOLOGIES OF STERILIZATION WITH OXONE, TSO3 INC
33 BLACK WATCH TRAIL
FAIRPORT,  NY  14450
Correspondent Contact CHARLES O HANCOCK
Regulation Number880.2800
Classification Product Code
JOJ  
Date Received04/11/2002
Decision Date 08/27/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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