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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 K214057
Device Name STATIM 6000B Vacuum Autoclave
Applicant
SciCan Ltd.
1440 Don Mills Road
Toronto,  CA M3B 3P9
Applicant Contact Teresa Boyce
Correspondent
SciCan Ltd.
1440 Don Mills Road
Toronto,  CA M3B 3P9
Correspondent Contact Teresa Boyce
Regulation Number880.6880
Classification Product Code
FLE  
Date Received12/27/2021
Decision Date 03/31/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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