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FDA 510(k) Application Details - K132439
Device Classification Name
Sterilizer, Steam
More FDA Info for this Device
510(K) Number
K132439
Device Name
Sterilizer, Steam
Applicant
SAKURA SEIKI CO., LTD.
55 Northern Blvd
Suite 200
Great Neck, NY 11021 US
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Contact
MARIA F GRIFFIN
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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
08/05/2013
Decision Date
01/06/2014
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
Y
Expedited Review
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