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FDA 510(k) Application Details - K002045
Device Classification Name
Subsystem, Water Purification
More FDA Info for this Device
510(K) Number
K002045
Device Name
Subsystem, Water Purification
Applicant
TOTAL WATER TREATMENT SYSTEMS, INC.
4806 EAST BROADWAY
MADISON, WI 53716 US
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Contact
KENNETH J CLARK
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
07/05/2000
Decision Date
02/16/2001
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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