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

    PDI SURGICAL SCRUB/BRUSH T150-70

    K Number: K833549 · Decision Nov 28, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    570
    Registration Numbers
    570
    Same Product Code
    87
    Applicant Total
    9
    Review Days
    88

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    Basic Information

    Device Name
    PDI SURGICAL SCRUB/BRUSH T150-70
    K Number
    K833549
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4014
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Nice-Pak Products, Inc.
    Date Received
    September 1, 1983
    Decision Date
    November 28, 1983
    Product Code
    NAB
    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
    NAB Gauze / Sponge,Nonresorbable For External Use

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    K781539 ISO-CARE KIT
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