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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 K173633
Device Name VERIFY All-In-One STEAM Reusable Test Pack, VERIFY All-In-One STEAM Reusable Test Pack with Step Counter, VERIFY All-In-One STEAM Reusable Test Pack with Tracker Tag
Applicant
Steris Corporation
5960 Heisley Road
Mentor,  OH  44060
Applicant Contact Jennifer Nalepka
Correspondent
Steris Corporation
5960 Heisley Road
Mentor,  OH  44060
Correspondent Contact Jennifer Nalepka
Regulation Number880.2800
Classification Product Code
FRC  
Date Received11/24/2017
Decision Date 02/28/2018
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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