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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 K091136
Device Name AMSCO EVOLUTION MEDIUM STEAM STERILIZER, MODEL HC-900 AND HC-1200
Applicant
STERIS Corporation
5960 Heisley Road
Mentor,  OH  44060
Applicant Contact ROBERT F SULLIVAN
Correspondent
STERIS Corporation
5960 Heisley Road
Mentor,  OH  44060
Correspondent Contact ROBERT F SULLIVAN
Regulation Number880.6880
Classification Product Code
FLE  
Date Received04/20/2009
Decision Date 06/29/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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