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510(k) K151971

STERRAD CYCLESURE 24 Biological Indicator by Advanced Sterilization Products — Product Code FRC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 29, 2015
Date Received
July 16, 2015
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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