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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
FOIA Releasable 510(k) K063876
Device Name MODULAR DISINFECTION SYSTEM (MDS) FOR ENDOSCOPE REPROCESSING
Applicant
Medivators Reprocessing Systems
14605 28th Ave. N.
Minneapolis,  MN  55447
Applicant Contact LYNN LUEDERS
Correspondent
Medivators Reprocessing Systems
14605 28th Ave. N.
Minneapolis,  MN  55447
Correspondent Contact LYNN LUEDERS
Regulation Number876.1500
Classification Product Code
FEB  
Date Received12/29/2006
Decision Date 06/14/2007
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
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