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FDA 510(k) Application Details - K180342
Device Classification Name
Sterilant, Medical Devices
More FDA Info for this Device
510(K) Number
K180342
Device Name
Sterilant, Medical Devices
Applicant
Steris Corporations
5960 Heisley Road
Mentor, OH 44060 US
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Contact
Jennifer Nalepka
Other 510(k) Applications for this Contact
Regulation Number
880.6885
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Classification Product Code
MED
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More FDA Info for this Product Code
Date Received
02/07/2018
Decision Date
04/04/2018
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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