Nutrisafe 2- ENFit Adaptor— 510(k) K151237

Substantially Equivalent

Vygon

FDA 510(k) clearance K151237 for Nutrisafe 2- ENFit Adaptor, Substantially Equivalent on 2016-02-09. Applicant: Vygon. Device class: 2.

Clearance details

Applicant: Vygon
Product code: Code PIO
Device class: Class 2
Regulation: 21 CFR 876.5980
Advisory panel: Gastroenterology, Urology
Date received: 2015-05-11
Decision date: 2016-02-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lansdale Montgomery, PA, US

Download summary PDF View on FDA.gov ↗

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