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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 K072510
Device Name VERIFY V-PRO CHEMICAL INDICATOR, VERSIONS 1 AND 2
Applicant
STERIS Corporation
5960 Heisley Road
Mentor,  OH  44060
Applicant Contact JOHN ROBERT SCOVILLE
Correspondent
STERIS Corporation
5960 Heisley Road
Mentor,  OH  44060
Correspondent Contact JOHN ROBERT SCOVILLE
Regulation Number880.2800
Classification Product Code
JOJ  
Date Received09/06/2007
Decision Date 12/11/2007
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
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