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FDA 510(k) Application Details - K992793
Device Classification Name
Tank, Holding, Dialysis
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510(K) Number
K992793
Device Name
Tank, Holding, Dialysis
Applicant
BETTER WATER, INC.
698 SWAN DR.
SMYRNA, TN 37167 US
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Contact
MIKE S STERLING
Other 510(k) Applications for this Contact
Regulation Number
876.5820
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Classification Product Code
FIN
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
08/19/1999
Decision Date
11/16/1999
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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