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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 K212424
Device Name AMSCO 400 Small Steam Sterilizers, AMSCO 400 Medium Steam Sterilizers
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 Received08/04/2021
Decision Date 10/28/2021
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
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