BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇹🇼 Taiwan

    BORRION ENTERPRISE CO

    K Number: K941340 · Decision May 17, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    1549
    Registration Numbers
    1550
    Same Product Code
    645
    Applicant Total
    1
    Review Days
    57

    Basic Information

    Device Name
    BORRION ENTERPRISE CO
    K Number
    K941340
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    886.5850
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    BORRION ENTERPRISE CO.
    Date Received
    March 21, 1994
    Decision Date
    May 17, 1994
    Product Code
    HQY
    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
    HQY Sunglasses (Non-Prescription Including Photosensitive)

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