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FDA 510(k) Application Details - K153784
Device Classification Name
System, Water Purification, General Medical Use
More FDA Info for this Device
510(K) Number
K153784
Device Name
System, Water Purification, General Medical Use
Applicant
Evoqua Water Technologies, LLC
10 Technology Drive
Lowell, MA 01851 US
Other 510(k) Applications for this Company
Contact
Robert Dudek
Other 510(k) Applications for this Contact
Regulation Number
876.5665
More FDA Info for this Regulation Number
Classification Product Code
NHV
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
12/31/2015
Decision Date
10/21/2016
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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