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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 K040049
Device Name THE RELIANCE ENDOSCOPE PROCESSING SYSTEM
Applicant
STERIS CORPORATION
5960 heisley road
mentor,  OH  44060
Contact nancy a robinson
Regulation Number876.1500
Classification Product Code
NZA  
Date Received01/12/2004
Decision Date 12/17/2004
Decision substantially equivalent (SE)
Classification Advisory Committee Gastroenterology/Urology
Review Advisory Committee General Hospital
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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