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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 K152630
Device Name VERIFY STEAM Integrating Indicator
Applicant
STERIS CORPORATION
5960 HEISLEY ROAD
MENTOR,  OH  44060
Applicant Contact BILL BRODBECK
Correspondent
STERIS CORPORATION
5960 HEISLEY ROAD
MENTOR,  OH  44060
Correspondent Contact BILL BRODBECK
Regulation Number880.2800
Classification Product Code
JOJ  
Date Received09/15/2015
Decision Date 05/12/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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