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FDA 510(k) Application Details - K172432
Device Classification Name
Indicator, Biological Sterilization Process
More FDA Info for this Device
510(K) Number
K172432
Device Name
Indicator, Biological Sterilization Process
Applicant
Crosstex/SPSmedical, A Division of Cantel Medical
6789 West Henrietta Road
Rush, NY 14543 US
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Contact
Megan Skaar
Other 510(k) Applications for this Contact
Regulation Number
880.2800
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Classification Product Code
FRC
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More FDA Info for this Product Code
Date Received
08/11/2017
Decision Date
12/12/2017
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
N
Expedited Review
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