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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 K090636
Device Name TSO3 OZONE STERILIZER, MODEL 125L
Applicant
Tso3, Inc.
33 Black Watch Trail
Fairport,  NY  14450
Applicant Contact CHARLES O HANCOCK
Correspondent
Tso3, Inc.
33 Black Watch Trail
Fairport,  NY  14450
Correspondent Contact CHARLES O HANCOCK
Regulation Number880.6860
Classification Product Code
FLF  
Date Received03/10/2009
Decision Date 12/02/2009
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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