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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 K103053
Device Name VERIFY 270FP CHALLENGE PACK
Applicant
STERIS Corporation
5960 Heisley Road
Mentor,  OH  44060
Applicant Contact ROBERT SULLIVAN
Correspondent
STERIS Corporation
5960 Heisley Road
Mentor,  OH  44060
Correspondent Contact ROBERT SULLIVAN
Regulation Number880.2800
Classification Product Code
JOJ  
Date Received10/15/2010
Decision Date 03/10/2011
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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