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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Indicator, Physical/Chemical Sterilization Process
510(k) Number K112256
Device Name STERIS STEAM PI
Applicant
STERIS Corporation
5960 Heisley Rd.
Mentor,  OH  44060
Applicant Contact ROBERT SULLIVAN
Correspondent
STERIS Corporation
5960 Heisley Rd.
Mentor,  OH  44060
Correspondent Contact ROBERT SULLIVAN
Regulation Number880.2800
Classification Product Code
JOJ  
Date Received08/05/2011
Decision Date 01/11/2012
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
Predetermined Change
Control Plan Authorized		 No
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