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FDA 510(k) Application Details - K091136
Device Classification Name
Sterilizer, Steam
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510(K) Number
K091136
Device Name
Sterilizer, Steam
Applicant
STERIS Corporation
5960 Heisley Road
Mentor, OH 44060 US
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Contact
ROBERT F SULLIVAN
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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
04/20/2009
Decision Date
06/29/2009
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Summary
Type
Abbreviated
Reviewed By Third Party
N
Expedited Review
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