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510(k) Data Aggregation

    K Number
    K964240
    Device Name
    BIAFINE WOUND DRESSING EMULSION
    Manufacturer
    MEDIX PHARMACEUTICALS AMERICAS, INC.
    Date Cleared
    1997-01-22

    (90 days)

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

    MEDIX PHARMACEUTICALS AMERICAS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    BIAFINE™ is intended to be used as a wound dressing for the following indications: - superficial wounds - minor abrasions - leg ulcers - donor sites - 1st and 2nd degree burns, including sunburns - radiation dermatitis - for dermal ulcers, including full thickness wounds and pressure sores, consult a plysician
    Device Description
    BIAFINE® Wound Dressing Emulsion
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