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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Liquid Chemical Processing System
510(k) Number K180553
Device Name VERIFY Spore Test Strip for S40 Sterilant
Applicant
STERIS Corporation
5960 Heisley Rd.
Mentor,  OH  44060
Applicant Contact Marcia L. Benedict
Correspondent
STERIS Corporation
5960 Heisley Rd.
Mentor,  OH  44060
Correspondent Contact Marcia L. Benedict
Regulation Number880.6887
Classification Product Code
OVY  
Date Received03/01/2018
Decision Date 05/29/2018
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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