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510(k) Data Aggregation

    K Number
    K990861
    Device Name
    WOUND DRESSING/ABD PAD, MODEL #10810
    Manufacturer
    HOSPITAL SPECIALTY CO.
    Date Cleared
    1999-04-12

    (27 days)

    Product Code
    FRO
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    HOSPITAL SPECIALTY CO.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The pad is used to cover wounds
    Device Description
    The pad is composed of the same type of materials as the predicate device. The non-woven outer-wrap has been tested according to the Intensified Shelasnski Repeated Insult Patch Test and is neither a skin irritant nor a skin sensitizer. The pads are available in the same sizes and similar weights.
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