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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Wrap, Sterilization
510(k) Number K231500
Device Name Vis-U-All Low Temperature Sterilization Pouches
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 Number880.6850
Classification Product Code
FRG  
Date Received05/24/2023
Decision Date 08/07/2023
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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