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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 K032004
Device Name AQUABOSS ECORO DIA 50
Applicant
LAUER LTD., HONG KONG
SPEICHERMATT 9
WITTLINGEN,  DE 79599
Applicant Contact STEPHAN KRIETEMEYER
Correspondent
TUV AMERICA, INC.
1775 OLD HIGHWAY 8
NEW BRIGHTON,  MN  55112 -1891
Correspondent Contact STEFAN PREISS
Regulation Number876.5665
Classification Product Code
FIP  
Date Received06/30/2003
Decision Date 10/02/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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