FDA 510(k) Application Details - K110578

Device Classification Name Subsystem, Water Purification

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510(K) Number K110578
Device Name Subsystem, Water Purification
Applicant MAR COR PURIFICATION, INC.
14605 28TH AVENUE NORTH
MINNEAPOLIS, MN 55447 US
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Contact Brent Geiger
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Regulation Number 876.5665

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Classification Product Code FIP
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Date Received 03/01/2011
Decision Date 05/20/2011
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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