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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 K010865
Device Name AMSCO CENTURY MEDIUM STERILIZER, MODEL CENTURY
Applicant
STERIS Corporation
5960 Heisley Road
Mentor,  OH  44060
Applicant Contact RAYMOND URSICK
Correspondent
STERIS Corporation
5960 Heisley Road
Mentor,  OH  44060
Correspondent Contact RAYMOND URSICK
Regulation Number880.6880
Classification Product Code
FLE  
Date Received03/22/2001
Decision Date 05/31/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Abbreviated
Reviewed by Third Party No
Combination Product No
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