BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    SPLINT, PNEUMATIC, ARM & SPLINT, PNEUMATIC, LEG

    K Number: K941869 · Decision Aug 3, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    90
    Registration Numbers
    90
    Same Product Code
    36
    Applicant Total
    2
    Review Days
    107

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    Basic Information

    Device Name
    SPLINT, PNEUMATIC, ARM & SPLINT, PNEUMATIC, LEG
    K Number
    K941869
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6320
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    The Lighthouse For the Blind, Inc.
    Date Received
    April 18, 1994
    Decision Date
    August 3, 1994
    Product Code
    KZF
    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
    KZF Device, Medical Examination, Ac Powered

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