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

    AROMATIC AND FLAVORED TONGUE DEPRESSOR

    K Number: K992995 · Decision Dec 9, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    219
    Registration Numbers
    219
    Same Product Code
    4
    Applicant Total
    2
    Review Days
    93

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    AROMATIC AND FLAVORED TONGUE DEPRESSOR
    K Number
    K992995
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6230
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Aga Plastic Ind. Com. Ltda.
    Date Received
    September 7, 1999
    Decision Date
    December 9, 1999
    Product Code
    FMA
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

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

    Product Code Device Name
    FMA Depressor, Tongue, Non-Surgical

    Similar 510(k) Clearances

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

    TONGUE DEPRESSOR

    FDA 510(k)
    FDA Class 1 ·General Hospital

    MINI LANCET-BLOOD LANCET

    FDA 510(k)
    FDA Class 1 ·General Hospital

    BITE STICK

    FDA 510(k)
    FDA Class 1 ·General Hospital

    MOUTH WASH TRAY

    FDA 510(k)
    FDA Class 1 ·General Hospital
    View all

    Other Clearances by Aga Plastic Ind. Com. Ltda.

    K Number Device Name
    K101348 AGACHAMBER SPACER