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FDA 510(k) Application Details - K043482
Device Classification Name
Indicator, Physical/Chemical Sterilization Process
More FDA Info for this Device
510(K) Number
K043482
Device Name
Indicator, Physical/Chemical Sterilization Process
Applicant
STERIS Corporation
5960 Heisley Road
Mentor, OH 44060 US
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Contact
MARGARET MARSH
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Regulation Number
880.2800
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Classification Product Code
JOJ
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More FDA Info for this Product Code
Date Received
12/17/2004
Decision Date
12/21/2004
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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