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

    PLURA-GARD CHEST DRAINAGE SYSTEM

    K Number: K844942 · Decision Mar 12, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    276
    Registration Numbers
    276
    Same Product Code
    47
    Applicant Total
    15
    Review Days
    82

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    Basic Information

    Device Name
    PLURA-GARD CHEST DRAINAGE SYSTEM
    K Number
    K844942
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.6740
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Consolidated Medical Equipment, Inc.
    Date Received
    December 20, 1984
    Decision Date
    March 12, 1985
    Product Code
    KDQ
    Advisory Committee
    General Hospital
    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
    KDQ Bottle, Collection, Vacuum

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