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

    BLACHLY BITE BLOK & CHEEK FILLER

    K Number: K770090 · Decision Jan 31, 1977
    View on FDA
    Classifications
    1
    FEI Numbers
    15
    Registration Numbers
    15
    Same Product Code
    27
    Applicant Total
    1
    Review Days
    14

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    Basic Information

    Device Name
    BLACHLY BITE BLOK & CHEEK FILLER
    K Number
    K770090
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.5070
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Applicant
    P.H. Blachly, M.D.
    Date Received
    January 17, 1977
    Decision Date
    January 31, 1977
    Product Code
    JXL
    Advisory Committee
    Neurology
    Review Advisory Committee
    NE
    Third Party
    N

    Classifications

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

    Product Code Device Name
    JXL Block, Bite

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