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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Sterilizer, Ethylene-Oxide Gas
510(k) Number K020875
Device Name TSO3 OZONE STERILIZER, MODEL 125L
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 Number880.6860
Classification Product Code
FLF  
Subsequent Product Code
FRC  
Date Received03/18/2002
Decision Date 08/26/2003
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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