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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name subsystem, water purification
510(k) Number K124059
Device Name AQUABOSS ECORO DIA I (HT); AQUABOSS ECORO DIA II (HT)
Applicant
LAUER MEMBRAN WASSERTECHNIK GMBH
9 SPEICHERMATT
WITTLINGEN,  DE DE 79599
Applicant Contact STEPHAN KRIETEMEYER
Correspondent
LAUER MEMBRAN WASSERTECHNIK GMBH
9 SPEICHERMATT
WITTLINGEN,  DE DE 79599
Correspondent Contact STEPHAN KRIETEMEYER
Regulation Number876.5665
Classification Product Code
FIP  
Date Received12/31/2012
Decision Date 03/25/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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