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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 K133829
Device Name AQUABPLUS,AQUABPLUS & AQUABPLUS B2,AQUABPLUS&AQUABPLUS HF,AQUABPLUS& AQUABPLUS B2& AQUABLUS HF
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 Received12/17/2013
Decision Date 04/22/2014
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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