FDA 510(k) K192869, SherpaPak Lung Preservation System , SherpaPak Liver Transport System, Northstar Biomedical Associates

FDA 510(k) K192869, SherpaPak Lung Preservation System , SherpaPak Liver Transport System, Northstar Biomedical Associates

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510(K) Number: K192869
Device Name: SherpaPak Lung Preservation System , SherpaPak Liver Transport System
Manufacturer: Northstar Biomedical Associates
Device Classification Name: System, Perfusion, Kidney
Regulation Number: 876.5880
Classification Product Code: KDN
Date Received: 10/07/2019
Decision Date: 01/16/2020
Regulation Medical Specialty: Gastroenterology/Urology

PLEASE NOTE: Most 510(k)s obtained through FOIA are heavily redacted, often omitting sections related to testing, software, manufacturing, and other technical data. Please be sure to review the total pages, redacted pages, and content pages listed in the description to get a sense of how much of the document is redacted. As the FDA FOIA office explains: “We HEAVILY REDACT the majority of the following portions of 510(k) filings: testing data, technical data, lab reports, manufacturing information, vendor information, substantive discussions regarding deficiencies or additional information requests, internal FDA communications, software and risk analysis, specifications, SOPs, unpublished studies, draft manuals, etc.” If you’d like more details about a specific document before purchasing, please contact us at info@foiadocs.com.

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