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

    UNIVERSAL BONE CEMENT KIT

    K Number: K931540 · Decision Jan 27, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    55
    Registration Numbers
    55
    Same Product Code
    36
    Applicant Total
    30
    Review Days
    304

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    Basic Information

    Device Name
    UNIVERSAL BONE CEMENT KIT
    K Number
    K931540
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.3300
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Biodynamic Technologies, Inc.
    Date Received
    March 29, 1993
    Decision Date
    January 27, 1994
    Product Code
    LZN
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    OR
    Third Party
    N

    Classifications

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

    Product Code Device Name
    LZN Cement Obturator

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