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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name sterilizer, steam
510(k) Number K112872
Model G4-121101, G4-201103
Device Name STATIM 2000 G4 CASSETTE
Original Applicant
1440 don mills rd.
toronto, ontario,  CA m3b 3p9
Original Contact teresa boyce
Regulation Number880.6880
Classification Product Code
Date Received09/30/2011
Decision Date 07/10/2012
Decision substantially equivalent (SE)
Classification Advisory Committee General Hospital
Review Advisory Committee General Hospital
statement statement
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No