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

    ORAL SPONGE

    K Number: K830675 · Decision Mar 24, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    63
    Registration Numbers
    63
    Same Product Code
    1
    Applicant Total
    2
    Review Days
    21

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    Basic Information

    Device Name
    ORAL SPONGE
    K Number
    K830675
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4800
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Unisplint Corp.
    Date Received
    March 3, 1983
    Decision Date
    March 24, 1983
    Product Code
    GEO
    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
    GEO File, Surgical, General & Plastic Surgery

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (GEO), ordered by most recent decision date.

    GENERAL SURGICAL FILES

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery
    View all

    Other Clearances by Unisplint Corp.

    K Number Device Name
    K820944 DENTAL ARCH BAR