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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
SCICAN LTD.
1440 don mills rd.
toronto, ontario,  CA m3b 3p9
Original Contact teresa boyce
Regulation Number880.6880
Classification Product Code
FLE  
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
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