FDA 510(k) Application Details - K172677

Device Classification Name Accessories, Cleaning, For Endoscope

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510(K) Number K172677
Device Name Accessories, Cleaning, For Endoscope
Applicant Medivators Inc.
14605 28th Avenue North
Minneapolis, MN 55447 US
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Contact Megan Skaar
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Regulation Number 876.1500

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Classification Product Code FEB
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Date Received 09/05/2017
Decision Date 12/19/2017
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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