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FDA 510(k) Application Details - K214057
Device Classification Name
Sterilizer, Steam
More FDA Info for this Device
510(K) Number
K214057
Device Name
Sterilizer, Steam
Applicant
SciCan Ltd.
1440 Don Mills Road
Toronto M3B 3P9 CA
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Contact
Teresa Boyce
Other 510(k) Applications for this Contact
Regulation Number
880.6880
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Classification Product Code
FLE
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More FDA Info for this Product Code
Date Received
12/27/2021
Decision Date
03/31/2022
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Statement
Type
Abbreviated
Reviewed By Third Party
N
Expedited Review
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