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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 K070461
Device Name VERIFY STEAM INDICATORS, MODELS 250F 25, 250F 30, 270F 15, 270F 3-10 AND 270F 4
STERIS Corporation
5960 Heisley Road
Mentor,  OH  44060
Applicant Contact JOHN SCOVILLE
STERIS Corporation
5960 Heisley Road
Mentor,  OH  44060
Correspondent Contact JOHN SCOVILLE
Regulation Number880.2800
Classification Product Code
Date Received02/16/2007
Decision Date 07/17/2007
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