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FDA 510(k) Application Details - K121618
Device Classification Name
Set, Perfusion, Kidney, Disposable
More FDA Info for this Device
510(K) Number
K121618
Device Name
Set, Perfusion, Kidney, Disposable
Applicant
WATERS MEDICAL SYSTEMS, LLC
2112 15TH ST. N.W.
ROCHESTER, MN 55901 US
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Contact
ROBERT WARREN
Other 510(k) Applications for this Contact
Regulation Number
876.5880
More FDA Info for this Regulation Number
Classification Product Code
KDL
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
06/01/2012
Decision Date
06/14/2013
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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