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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 K163609
Device Name Pall QPoint Water Filter Capsule (Shower), Pall QPoint Water Filter Capsule (Faucet)
Applicant
Pall International Sarl
Ave. De Tivoli 3
Fribourg,  CH CH-1700
Applicant Contact Karen Peterson-Doyle
Correspondent
Hogan Lovells US LLP
555 Thirteenth St., NW
Washington, Dc,  DC  20004
Correspondent Contact Randy Prebula
Regulation Number876.5665
Classification Product Code
NHV  
Date Received12/22/2016
Decision Date 06/01/2017
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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