FDA 510(k) K844077, NUTRIMIX EMPTY CONTAINER, by Abbott Laboratories

FDA 510(k) K844077, NUTRIMIX EMPTY CONTAINER, by Abbott Laboratories

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Device Classification Name: Container, I.V.
510(k) Number: K844077
Device Name: NUTRIMIX EMPTY CONTAINER
Applicant: Abbott Laboratories
Regulation Number: 880.5025
Classification Product Code: KPE
Date Received: 10/19/1984
Decision Date: 02/15/1985
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: General Hospital
510k Review Panel: General Hospital

Total number of pages: 24
Fully redacted pages: 0
Content pages: 24

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or additional information requests, internal FDA communications, software and risk analysis, specifications, SOPs, unpublished studies, draft manuals, etc.”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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