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FDA 510(k) Application Details - K124059
Device Classification Name
Subsystem, Water Purification
More FDA Info for this Device
510(K) Number
K124059
Device Name
Subsystem, Water Purification
Applicant
LAUER MEMBRAN WASSERTECHNIK GMBH
9 SPEICHERMATT
WITTLINGEN DE 79599 DE
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Contact
STEPHAN KRIETEMEYER
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
12/31/2012
Decision Date
03/25/2013
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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