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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 K102996
FOIA Releasable 510(k) K102996
Device Name MEDIVATORS ADVANTAGE PLUS ENDOSCOPE REPROCESSOR
Applicant
MEDIVATORS REPROCESSING SYSTEMS
14605 28TH AVE., NORTH
MINNEAPOLIS,  MN  55447 -4822
Applicant Contact LYNN LUEDERS
Correspondent
MEDIVATORS REPROCESSING SYSTEMS
14605 28TH AVE., NORTH
MINNEAPOLIS,  MN  55447 -4822
Correspondent Contact LYNN LUEDERS
Regulation Number876.1500
Classification Product Code
FEB  
Date Received10/07/2010
Decision Date 01/13/2011
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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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