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

    DELTA SCRUB

    K Number: K872823 · Decision Jan 7, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    126
    Registration Numbers
    126
    Same Product Code
    36
    Applicant Total
    1
    Review Days
    175

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    Basic Information

    Device Name
    DELTA SCRUB
    K Number
    K872823
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4800
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Pacific Biosystems, Inc.
    Date Received
    July 16, 1987
    Decision Date
    January 7, 1988
    Product Code
    GEC
    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
    GEC Brush, Scrub, Operating-Room

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