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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 K140499
Device Name VERIFY V24 SELF-CONTAINED BIOLOGICAL INDICATOR FOR VAPORIZED VH202 STERILIZATION PROCESSES
Applicant
STERIS Corporation
5960 Heisley Road
Mentor,  OH  44060
Applicant Contact BILL BRODBECK
Correspondent
STERIS Corporation
5960 Heisley Road
Mentor,  OH  44060
Correspondent Contact BILL BRODBECK
Regulation Number880.2800
Classification Product Code
FRC  
Date Received02/27/2014
Decision Date 07/17/2014
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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