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

    DISARP ORIGINAL

    K Number: K802248 · Decision Sep 26, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    18
    Registration Numbers
    18
    Same Product Code
    3
    Applicant Total
    7
    Review Days
    10

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    Basic Information

    Device Name
    DISARP ORIGINAL
    K Number
    K802248
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4495
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Unoplast A/S
    Date Received
    September 16, 1980
    Decision Date
    September 26, 1980
    Product Code
    GAO
    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
    GAO Suture, Nonabsorbable

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