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FDA 510(k) Application Details - K151637
Device Classification Name
Subsystem, Water Purification
More FDA Info for this Device
510(K) Number
K151637
Device Name
Subsystem, Water Purification
Applicant
Specialty Water Technologies
1020 Industrial Drive
Orlinda, TN 37141 US
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Contact
Alex Clark
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
06/17/2015
Decision Date
09/23/2015
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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