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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Water Purification, General Medical Use
510(k) Number K153434
Device Name Pall-Aquasafe Water Filter
Applicant
Pall International Sarl
Ave De Tivoli 3
Fribourg,  CH 1700
Applicant Contact KAREN D PETERSON-DOYLE
Correspondent
Pall International Sarl
Ave De Tivoli 3
Fribourg,  CH 1700
Correspondent Contact KAREN D PETERSON-DOYLE
Regulation Number876.5665
Classification Product Code
NHV  
Date Received11/27/2015
Decision Date 06/10/2016
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
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