FDA 510(K) K100434, CLAVE NEUTRON

FDA 510(K) K100434, CLAVE NEUTRON

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Device Classification Name    Set, Administration, Intravascular
510(k) Number    K100434
Device Name    CLAVE NEUTRON
Applicant    ICU MEDICAL, INC.
Regulation Number    880.5440
Classification Product Code    FPA  
Subsequent Product Code    KGZ  
Date Received    02/16/2010
Decision Date    07/09/2010
Decision    Substantially Equivalent (SESE)
Regulation Medical Specialty    General Hospital

Total pages: 623  
Fully redacted pages: 463  
Content pages: 160 

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or additional information requests, internal FDA communications, software and risk analysis, specifications, SOPs, unpublished studies, draft manuals, etc.”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