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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name sterilizer, chemical
510(k) Number K223476
Device Name V-PRO maX 2 Low Temperature Sterilization System
Applicant
Steris Corporation
5960 Heisley Rd
Mentor,  OH  44060
Applicant Contact Anthony Piotrkowski
Correspondent
Steris Corporation
5960 Heisley Rd
Mentor,  OH  44060
Correspondent Contact Anthony Piotrkowski
Regulation Number880.6860
Classification Product Code
MLR  
Date Received11/18/2022
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
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