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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name sterilizer, steam
510(k) Number K173485
Device Name Amsco Evolution Medium Steam Sterilizer
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 Number880.6880
Classification Product Code
FLE  
Date Received11/13/2017
Decision Date 02/22/2018
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
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