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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 K183300
Device Name VERIFY V24 Self-Contained Biological Indicator, VERIFY V24 Biological Indicator Challenge Pack
Applicant
STERIS Corporations
5960 Heisley Road
Mentor,  OH  44060
Applicant Contact Gregory Land
Correspondent
STERIS Corporations
5960 Heisley Road
Mentor,  OH  44060
Correspondent Contact Gregory Land
Regulation Number880.2800
Classification Product Code
FRC  
Date Received11/27/2018
Decision Date 01/03/2019
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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