SherpaPak Lung Preservation System , SherpaPak Liver Transport System— 510(k) K192869

Name: FDA 510(k) clearance K192869
Creator: U.S. Food and Drug Administration
Published: 2020-01-16

Unknown

Pragonix Technologies

FDA 510(k) clearance K192869 for SherpaPak Lung Preservation System , SherpaPak Liver Transport System, Unknown on 2020-01-16. Applicant: Pragonix Technologies. Device class: 2.

Clearance details

Applicant: Pragonix Technologies
Product code: Code KDN
Device class: Class 2
Regulation: 21 CFR 876.5880
Advisory panel: Gastroenterology, Urology
Date received: 2019-10-07
Decision date: 2020-01-16
Decision: Unknown
Clearance type: Traditional
Location: Braintree, MA, US

Download summary PDF View on FDA.gov ↗

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