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510(k) Data Aggregation

    K Number
    K973693
    Device Name
    AQUA PATCH
    Manufacturer
    Date Cleared
    1997-12-18

    (83 days)

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

    PCI TECHNOLOGY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Dermal ulcers, superficial wounds, 1st and 2nd degree burns, donor sites, skin tears, radiation reactions (burns), protection around tube sites.
    Device Description
    Aqua Patch Hydrogel Dressing
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