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510(k) K122044

STERRAD(R) CYCLESURE(R) 24 BIOLOGICAL INDICATOR by Advanced Sterilization Products — Product Code FRC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 4, 2012
Date Received
July 12, 2012
Clearance Type
Special
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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