Pall-Aquasafe Water Filter— 510(k) K153434

Name: FDA 510(k) clearance K153434
Creator: U.S. Food and Drug Administration
Published: 2016-06-10

Substantially Equivalent

Pall International Sarl

FDA 510(k) clearance K153434 for Pall-Aquasafe Water Filter, Substantially Equivalent on 2016-06-10. Applicant: Pall International Sarl. Device class: 2.

Clearance details

Applicant: Pall International Sarl
Product code: Product code NHV
Device class: Class 2
Regulation: 21 CFR 876.5665
Advisory panel: Gastroenterology, Urology
Date received: 2015-11-27
Decision date: 2016-06-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fribourg, CH

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.