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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 K143617
Device Name AquaC UNO H
Applicant
VIVONIC GMBH
KURFUERST-EPPSTEIN-RING 4
SAILAUF,  DE 63877
Applicant Contact Andreas Hessberger
Correspondent
VIVONIC GMBH
KURFUERST-EPPSTEIN-RING 4
SAILAUF,  DE 63877
Correspondent Contact Andreas Hessberger
Regulation Number876.5665
Classification Product Code
FIP  
Date Received12/19/2014
Decision Date 10/19/2015
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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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