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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name indicator, biological sterilization process
510(k) Number K122044
Device Name STERRAD(R) CYCLESURE(R) 24 BIOLOGICAL INDICATOR
Original Applicant
ADVANCED STERILIZATION PRODUCTS
33 technology drive
irvine,  CA  92618
Original Contact nancy chu
Regulation Number880.2800
Classification Product Code
FRC  
Date Received07/12/2012
Decision Date 10/04/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
summary summary
Type Special
Reviewed by Third Party No
Combination Product No
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