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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 K071014
Device Name MODIFICATION TO STERRAD CYCLESURE BIOLOGICAL INDICATOR
Applicant
ADVANCED STERILIZATION PRODUCTS
33 TECHNOLOGY DR.
IRVINE,  CA  92618
Applicant Contact YOGI SHAH
Correspondent
ADVANCED STERILIZATION PRODUCTS
33 TECHNOLOGY DR.
IRVINE,  CA  92618
Correspondent Contact YOGI SHAH
Regulation Number880.2800
Classification Product Code
FRC  
Date Received04/10/2007
Decision Date 05/24/2007
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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