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

    NIL

    K Number: K943613 · Decision Sep 21, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    664
    Registration Numbers
    664
    Same Product Code
    10
    Applicant Total
    2
    Review Days
    56

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    Basic Information

    Device Name
    NIL
    K Number
    K943613
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    886.5840
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Sing Wah International Enterprises , Ltd.
    Date Received
    July 27, 1994
    Decision Date
    September 21, 1994
    Product Code
    HOI
    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
    HOI Spectacle, Magnifying

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    Other Clearances by Sing Wah International Enterprises , Ltd.

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