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

    PERIMETER CLOSED WOUND RESEVOIR

    K Number: K844921 · Decision Mar 18, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    220
    Registration Numbers
    220
    Same Product Code
    95
    Applicant Total
    5
    Review Days
    89

    Basic Information

    Device Name
    PERIMETER CLOSED WOUND RESEVOIR
    K Number
    K844921
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4680
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    PERIMETER MEDICAL, INC.
    Date Received
    December 19, 1984
    Decision Date
    March 18, 1985
    Product Code
    GCY
    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
    GCY Apparatus, Suction, Single Patient Use, Portable, Nonpowered

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    Other Clearances by PERIMETER MEDICAL, INC.

    K Number Device Name
    K844925 PERIMETER MEDIASTINAL DRAIN
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