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

    AMMI MAGNI-GUARD

    K Number: K961454 · Decision Jul 25, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    877
    Registration Numbers
    878
    Same Product Code
    55
    Applicant Total
    6
    Review Days
    101

    Basic Information

    Device Name
    AMMI MAGNI-GUARD
    K Number
    K961454
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4040
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    AMERICAN MEDICAL MFG., INC.
    Date Received
    April 15, 1996
    Decision Date
    July 25, 1996
    Product Code
    LYU
    Advisory Committee
    General, Plastic Surgery
    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
    LYU Accessory, Surgical Apparel

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