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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
Original Applicant
TECHNOLOGIES OF STERILIZATION WITH OXONE, TSO3 INC
33 black watch trail
fairport,  NY  14450
Original 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 (SE)
Classification Advisory Committee General Hospital
Review Advisory Committee General Hospital
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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