SherpaPak Pediatric Liver Transport System

System, Perfusion, Kidney

Paragonix Technologies

The following data is part of a premarket notification filed by Paragonix Technologies with the FDA for Sherpapak Pediatric Liver Transport System.

Pre-market Notification Details

Device IDK201048
510k NumberK201048
Device Name:SherpaPak Pediatric Liver Transport System
ClassificationSystem, Perfusion, Kidney
Applicant Paragonix Technologies Suite 408, 639 Granite Street Braintree,  MA  02184
ContactLisa Anderson
CorrespondentLeo Basta
Northstar Biomedical Associates 93 Benefit St Providence,  RI  02904
Product CodeKDN  
CFR Regulation Number876.5880 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-04-21
Decision Date2020-07-02

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