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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
Original Applicant
TSO3 INC.
33 black watch trail
fairport,  NY  14450
Original Contact charles o hancock
Regulation Number880.6860
Classification Product Code
FLF  
Date Received03/10/2009
Decision Date 12/02/2009
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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