BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    BIOSPONGE RECONSTRUCTION DISCS

    K Number: K771727 · Decision Sep 26, 1977
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    5
    Applicant Total
    82
    Review Days
    13

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    Basic Information

    Device Name
    BIOSPONGE RECONSTRUCTION DISCS
    K Number
    K771727
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    874.3620
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Applicant
    Xomed, Inc.
    Date Received
    September 13, 1977
    Decision Date
    September 26, 1977
    Product Code
    JOF
    Advisory Committee
    Ear, Nose, Throat
    Review Advisory Committee
    EN
    Third Party
    N

    Classifications

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

    Product Code Device Name
    JOF Polymer, Ent Synthetic, Porous Polyethylene

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