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

    SPINAL NEEDLES & ACCESSORY

    K Number: K834164 · Decision Dec 13, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    66
    Registration Numbers
    66
    Same Product Code
    63
    Applicant Total
    2
    Review Days
    12

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    Basic Information

    Device Name
    SPINAL NEEDLES & ACCESSORY
    K Number
    K834164
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5440
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Elfa Trading Co.
    Date Received
    December 1, 1983
    Decision Date
    December 13, 1983
    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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    Other Clearances by Elfa Trading Co.

    K Number Device Name
    K834165 SYRINGE