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FDA 510(k) Application Details - K192025
Device Classification Name
Indicator, Biological Sterilization Process
More FDA Info for this Device
510(K) Number
K192025
Device Name
Indicator, Biological Sterilization Process
Applicant
Advanced Sterilization Products (ASP)
33 Technology Drive
Irvine, CA 92618 US
Other 510(k) Applications for this Company
Contact
Elsie Kim
Other 510(k) Applications for this Contact
Regulation Number
880.2800
More FDA Info for this Regulation Number
Classification Product Code
FRC
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More FDA Info for this Product Code
Date Received
07/29/2019
Decision Date
01/23/2020
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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