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FDA 510(k) Application Details - K161844
Device Classification Name
Subsystem, Water Purification
More FDA Info for this Device
510(K) Number
K161844
Device Name
Subsystem, Water Purification
Applicant
BETTER WATER, LLC.
698 SWAN DR.
SMYRNA, TN 37167 US
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Contact
MIKE CLINE
Other 510(k) Applications for this Contact
Regulation Number
876.5665
More FDA Info for this Regulation Number
Classification Product Code
FIP
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
07/05/2016
Decision Date
12/13/2016
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
GU - Gastroenterology & Urology
Review Advisory Committee
GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Summary
Type
Abbreviated
Reviewed By Third Party
N
Expedited Review
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