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

    PYRAMID SUNGLASSES/PYRAMID READING GLASSES

    K Number: K931328 · Decision Aug 10, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    733
    Registration Numbers
    734
    Same Product Code
    10
    Applicant Total
    2
    Review Days
    147

    Basic Information

    Device Name
    PYRAMID SUNGLASSES/PYRAMID READING GLASSES
    K Number
    K931328
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    886.5840
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    PYRAMID
    Date Received
    March 16, 1993
    Decision Date
    August 10, 1993
    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 PYRAMID

    K Number Device Name
    K914425 PYRAMID SUNGLASSES/READING GLASSES