FDA 510(k) Application Details - K162471

Device Classification Name

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510(K) Number K162471
Device Name Hach CM130 Chlorine Monitoring System
Applicant HACH COMPANY
100 DAYTON AVENUE
AMES, IA 50010 US
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Contact Jeff Ryberg
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Regulation Number

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Classification Product Code PSX
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Date Received 09/06/2016
Decision Date 03/30/2017
Decision SESE - SUBST EQUIV
Classification Advisory Committee GU - Gastroenterology & Urology
Review Advisory Committee GU - Gastroenterology & Urology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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