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

    MODEL F 1 FLIP-UP SUNGLASSES W/POLORIZED LENS

    K Number: K900526 · Decision May 3, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    1390
    Registration Numbers
    1390
    Same Product Code
    645
    Applicant Total
    10
    Review Days
    90

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    Basic Information

    Device Name
    MODEL F 1 FLIP-UP SUNGLASSES W/POLORIZED LENS
    K Number
    K900526
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    886.5850
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Applicant
    J & B Assoc.
    Date Received
    February 2, 1990
    Decision Date
    May 3, 1990
    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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    Other Clearances by J & B Assoc.

    K Number Device Name
    K900521 MODEL N742 SUNGLASSES W/POLYCARBONATE BLUE BLOCKER
    K900524 MODEL F3 FLIP UP SUNGLASSES W/POLORIZED COMPUTER
    K900527 MODEL S139029 SUNGLASSES W/MIRROR ACRYLIC LENSES
    K900528 MODEL 8806 SD SUNGLASSES W/ACRYLIC LENSES
    K900529 MODEL 9018 PC SUNGLASSES W/POLYCARBONATE LENSES
    K900522 MODEL N741 SUNGLASSES W/ACRYLIC BLUE COMPUTER LENS
    K900520 MODEL N742 SUNGLASSES W/ACRYLIC NIGHT DRIVER LENS
    K900525 MODEL F 1 FLIP-UP SUNGLASSES W/POLYCARBONATE BLUE
    K900523 MODEL F3 FLIP-UP SUNGLASSES W/ACRYLIC ORANGE COMP.