483
Paragonix Technologies Inc.FDA 483 - Paragonix Technologies Inc.
Record Details
This document is a 510(k) clearance letter issued to Paragonix Technologies for their SherpaPak™ Lung Preservation System and SherpaPak™ Liver Transport System. The FDA determined these devices are substantially equivalent to legally marketed predicate devices. This clearance allows Paragonix Technologies to market the devices subject to general controls provisions.
- Company
- Paragonix Technologies Inc.
- Product type
- device
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ID · 40a575f4-af32-44b4-b75c-9eaee54f8b72
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