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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 K073618
Device Name VERIFY SIRIUS BIOLOGICAL INDICATOR CHALLENGE PACK
Applicant
STERIS Corporation
5960 Heisley Road
Mentor,  OH  44060
Applicant Contact JOHN R SCOVILLE
Correspondent
STERIS Corporation
5960 Heisley Road
Mentor,  OH  44060
Correspondent Contact JOHN R SCOVILLE
Regulation Number880.2800
Classification Product Code
FRC  
Date Received12/26/2007
Decision Date 01/07/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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