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

    REDYROB-CLOSED WOUND DRAINAGE SYSTEM

    K Number: K972703 · Decision Oct 1, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    213
    Registration Numbers
    213
    Same Product Code
    95
    Applicant Total
    149
    Review Days
    75

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    Basic Information

    Device Name
    REDYROB-CLOSED WOUND DRAINAGE SYSTEM
    K Number
    K972703
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4680
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    B.Braun Medical, Inc.
    Date Received
    July 18, 1997
    Decision Date
    October 1, 1997
    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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