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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name accessories, cleaning, for endoscope
510(K) Number K063876
Device Name MODULAR DISINFECTION SYSTEM (MDS) FOR ENDOSCOPE REPROCESSING
Applicant
MEDIVATORS REPROCESSING SYSTEMS
14605 28th ave., north
minneapolis,  MN  55447 4822
Contact lynn lueders
Regulation Number876.1500
Classification Product Code
FEB  
Date Received12/29/2006
Decision Date 06/14/2007
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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