Paragonix SherpaPak Pancreas Transport System— 510(k) K191440

Name: FDA 510(k) clearance K191440
Creator: U.S. Food and Drug Administration
Published: 2019-12-20

Substantially Equivalent

Paragonix Technologies

FDA 510(k) clearance K191440 for Paragonix SherpaPak Pancreas Transport System, Substantially Equivalent on 2019-12-20. Applicant: Paragonix Technologies. Device class: 2.

Clearance details

Applicant: Paragonix Technologies
Product code: Code KDN
Device class: Class 2
Regulation: 21 CFR 876.5880
Advisory panel: Gastroenterology, Urology
Date received: 2019-05-30
Decision date: 2019-12-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Braintree, MA, 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.