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510(k) Data Aggregation

    K Number
    K994199
    Device Name
    VARIOUS STERILE AND NON-STERILE SURGICAL DRAPES, (I.E., DISPOSABLES MINOR PROCEDURE DRAPES, LARGE APERTURE DRAPES, ABSOR
    Manufacturer
    CUSTOM MEDICAL PRODUCTS, INC.
    Date Cleared
    2000-06-09

    (179 days)

    Product Code
    KKX
    Regulation Number
    878.4370
    Why did this record match?
    Applicant Name (Manufacturer) :

    CUSTOM MEDICAL PRODUCTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Surgical Drapes are single use and shall be used by medical professionals in an operating room or healthcare setting for patient protective covering.
    Device Description
    Various Sterile and Non-Sterile Surgical Drapes, DISPOSABLES MINOR PROCEDURE DRAPES, LARGE APERTURE DRAPE, ABSORBANT ANG'IO GRAPHY SHEET, CEGEAREAN BIRTH SHEET AND POLY-U-DRAPE
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