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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 K162128
Device Name Scope Buddy Plus Endoscope Flushing Aid
Applicant
MEDIVATORS INC.
14605 28TH AVE. NORTH
MINNEAPOLIS,  MN  55447
Applicant Contact Kristin Bergeson Padilla
Correspondent
MEDIVATORS INC.
14605 28TH AVE. NORTH
MINNEAPOLIS,  MN  55447
Correspondent Contact Kristin Bergeson Padilla
Regulation Number876.1500
Classification Product Code
FEB  
Date Received08/01/2016
Decision Date 12/21/2016
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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