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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 K172748
Device Name VERIFY V24 Self-Contained Biological Indicator, VERIFY V24 Biological Indicator Challenge Pack
Applicant
Steris Corporations
5960 Heisley Rd.
Mentor,  OH  44060
Applicant Contact Jennifer Nalepka
Correspondent
Steris Corporations
5960 Heisley Rd.
Mentor,  OH  44060
Correspondent Contact Jennifer Nalepka
Regulation Number880.2800
Classification Product Code
FRC  
Date Received09/12/2017
Decision Date 02/09/2018
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
Predetermined Change
Control Plan Authorized		 No
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