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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 Trl.
Fairport,  NY  14450
Applicant Contact CHARLES O HANCOCK
Correspondent
Technologies of Sterilization With Oxone, Tso3, Inc.
33 Black Watch Trl.
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
Predetermined Change
Control Plan Authorized		 No
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