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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 trail
fairport,  NY  14450
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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