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FDA 510(k) Application Details - K110578
Device Classification Name
Subsystem, Water Purification
More FDA Info for this Device
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
Other 510(k) Applications for this Contact
Regulation Number
876.5665
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Classification Product Code
FIP
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More FDA Info for this Product Code
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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