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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Indicator, Physical/Chemical Sterilization Process
510(k) Number K241344
Device Name MetriCide™ OPA Plus Solution Test Strip
Applicant
Steris
5960 Heisley Rd.
Mentor,  OH  44060
Applicant Contact Anthony Piotrkowski
Correspondent
Steris
5960 Heisley Rd.
Mentor,  OH  44060
Correspondent Contact Anthony Piotrkowski
Regulation Number880.2800
Classification Product Code
JOJ  
Date Received05/13/2024
Decision Date 06/11/2024
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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