BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇭🇰 Hong Kong

    SPECTACLE FRAME

    K Number: K944313 · Decision Mar 28, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    1086
    Registration Numbers
    1086
    Same Product Code
    197
    Applicant Total
    1
    Review Days
    211

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    Basic Information

    Device Name
    SPECTACLE FRAME
    K Number
    K944313
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    886.5842
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Sun Hing Optical Manufactory , Ltd.
    Date Received
    August 29, 1994
    Decision Date
    March 28, 1995
    Product Code
    HQZ
    Advisory Committee
    Ophthalmic
    Review Advisory Committee
    OP
    Third Party
    N

    Classifications

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

    Product Code Device Name
    HQZ Frame, Spectacle

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