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510(k) K183300

VERIFY V24 Self-Contained Biological Indicator, VERIFY V24 Biological Indicator Challenge Pack by Steris Corporations — Product Code FRC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 3, 2019
Date Received
November 27, 2018
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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