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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name accessories, germicide, cleaning, for endoscopes
510(k) Number K102244
Device Name RELIANCE ENDOSCOPE PROCESSING SYSTEM
Applicant
STERIS Corporation
5960 Heisley Road
Mentor,  OH  44060
Applicant Contact ROBERT F SULLIVAN
Correspondent
STERIS Corporation
5960 Heisley Road
Mentor,  OH  44060
Correspondent Contact ROBERT F SULLIVAN
Regulation Number876.1500
Classification Product Code
NZA  
Date Received08/09/2010
Decision Date 12/03/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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