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

    TRIANGULAR SPONGES

    K Number: K953088 · Decision Sep 14, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    211
    Registration Numbers
    211
    Same Product Code
    110
    Applicant Total
    7
    Review Days
    73

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    Basic Information

    Device Name
    TRIANGULAR SPONGES
    K Number
    K953088
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4450
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Medical Perspectives Corp.
    Date Received
    July 3, 1995
    Decision Date
    September 14, 1995
    Product Code
    GDY
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    GDY Gauze/Sponge, Internal, X-Ray Detectable

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    Other Clearances by Medical Perspectives Corp.

    K Number Device Name
    K953060 ROSEBUD DISSECTOR
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    K953058 ROUND STICK SPONGES, FLAT STICK SPONGES
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    K953062 CHERRY DISSECTOR
    K953057 CYLINDRICAL SPONGE