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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 K233682
Device Name VERIFY SPORE TEST STRIP for S40 STERILANT CONCENTRATE
Applicant
STERIS Corporation
5960 Heisley Rd.
Mentor,  OH  44060
Applicant Contact Gregory Land
Correspondent
STERIS Corporation
5960 Heisley Rd.
Mentor,  OH  44060
Correspondent Contact Gregory Land
Regulation Number880.6887
Classification Product Code
OVY  
Date Received11/16/2023
Decision Date 12/15/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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