BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    POLYFIN EXTENSION SET, MODELS 126 AND 128

    K Number: K965208 · Decision Feb 26, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    66
    Registration Numbers
    66
    Same Product Code
    63
    Applicant Total
    48
    Review Days
    61

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    Basic Information

    Device Name
    POLYFIN EXTENSION SET, MODELS 126 AND 128
    K Number
    K965208
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5440
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Medtronic Minimed
    Date Received
    December 27, 1996
    Decision Date
    February 26, 1997
    Product Code
    FPK
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    FPK Tubing, Fluid Delivery

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