FDA 510(k) Application Details - K162128

Device Classification Name Accessories, Cleaning, For Endoscope

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510(K) Number K162128
Device Name Accessories, Cleaning, For Endoscope
Applicant MEDIVATORS INC.
14605 28TH AVE. NORTH
MINNEAPOLIS, MN 55447 US
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Contact Kristin Bergeson Padilla
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Regulation Number 876.1500

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Classification Product Code FEB
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Date Received 08/01/2016
Decision Date 12/21/2016
Decision SESE - SUBST EQUIV
Classification Advisory Committee GU - Gastroenterology & Urology
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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