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510(k) K200970

Self-Contained Biological Indicator by True Indicating, LLC — Product Code FRC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 28, 2020
Date Received
April 13, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Indicator, Biological Sterilization Process
Device Class
Class II
Regulation Number
880.2800
Review Panel
HO
Submission Type

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