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

    ACUVAC(TM) SUCTION RESERVOIR 400CC AND

    K Number: K801350 · Decision Jul 14, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    213
    Registration Numbers
    213
    Same Product Code
    95
    Applicant Total
    12
    Review Days
    35

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    Basic Information

    Device Name
    ACUVAC(TM) SUCTION RESERVOIR 400CC AND
    K Number
    K801350
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4680
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Innovative Surgical Products, Inc.
    Date Received
    June 9, 1980
    Decision Date
    July 14, 1980
    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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