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

    PHARMASEAL SCRUB CARE-SURGICAL SCRUB BRUSH SPONGES

    K Number: K854232 · Decision Dec 10, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    126
    Registration Numbers
    126
    Same Product Code
    36
    Applicant Total
    64
    Review Days
    50

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    Basic Information

    Device Name
    PHARMASEAL SCRUB CARE-SURGICAL SCRUB BRUSH SPONGES
    K Number
    K854232
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4800
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent for Some Indications
    Applicant
    American Pharmaseal Div. Ahsc
    Date Received
    October 21, 1985
    Decision Date
    December 10, 1985
    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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