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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
Device Name STATIM 2000 G4 CASSETTE
Applicant
Scican , Ltd.
1440 Don Mills Rd.
Toronto,  CA M3B 3P9
Applicant Contact TERESA BOYCE
Correspondent
Scican , Ltd.
1440 Don Mills Rd.
Toronto,  CA M3B 3P9
Correspondent Contact TERESA BOYCE
Regulation Number880.6880
Classification Product Code
FLE  
Date Received09/30/2011
Decision Date 07/10/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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