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FDA 510(k) Application Details - K120149
Device Classification Name
Sterilizer, Steam
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510(K) Number
K120149
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
01/18/2012
Decision Date
05/08/2012
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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