# FDA 483 - Paragonix Technologies Inc. - Unknown Date

Source: https://www.globalkeysolutions.net/records/483/paragonix-technologies-inc/40a575f4-af32-44b4-b75c-9eaee54f8b72

> FDA 483 for Paragonix Technologies Inc. on Unknown Date. Product: device. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Paragonix Technologies Inc.
- Product Type: device
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: 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.

## Related Documents

- [483 - 2022-11-03](https://www.globalkeysolutions.net/records/483/paragonix-technologies-inc/4cd30176-1701-4fe0-a138-288186ecf1fb)

Company: https://www.globalkeysolutions.net/companies/paragonix-technologies-inc/09a3628f-818c-4adf-a6c2-ce566dcedcb4

Office: https://www.globalkeysolutions.net/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd