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FDA 510(k) Application Details - K192445
Device Classification Name
Indicator, Physical/Chemical Sterilization Process
More FDA Info for this Device
510(K) Number
K192445
Device Name
Indicator, Physical/Chemical Sterilization Process
Applicant
Serim Research Corporation
3506 Reedy Drive
Elkhard, IN 46514 US
Other 510(k) Applications for this Company
Contact
Jackie Nelson
Other 510(k) Applications for this Contact
Regulation Number
880.2800
More FDA Info for this Regulation Number
Classification Product Code
JOJ
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
09/06/2019
Decision Date
04/02/2020
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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