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

    FRAY BIO-PUNCH

    K Number: K921822 · Decision Oct 28, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    840
    Registration Numbers
    840
    Same Product Code
    43
    Applicant Total
    1
    Review Days
    195

    Basic Information

    Device Name
    FRAY BIO-PUNCH
    K Number
    K921822
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4800
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    FRAY PRODUCTS CORP.
    Date Received
    April 16, 1992
    Decision Date
    October 28, 1992
    Product Code
    MDM
    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
    MDM Instrument, Manual, Surgical, General Use

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