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510(k) Data Aggregation

    K Number
    K974768
    Device Name
    PDI STERILE LUBRICATING JELLY
    Manufacturer
    NICE-PAK PRODUCTS, INC.
    Date Cleared
    1998-01-16

    (25 days)

    Product Code
    KMJ, DAT
    Regulation Number
    880.6375
    Why did this record match?
    Applicant Name (Manufacturer) :

    NICE-PAK PRODUCTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    PDI Sterile Lube Jelly is intended for use to lubricant a body orifice of a patient in order to facilitate the entry of a diagnostic or therapeutic medical device (such as a catheter, enema tip, or endoscope). The device is intended for use on order of a physician.
    Device Description
    Not Found
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