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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
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDIX PHARMACEUTICALS AMERICAS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    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

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for BIAFINE® Wound Dressing Emulsion. It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria.

    The letter explicitly states:

    • "We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent... to devices marketed in interstate commerce prior to May 28, 1976..."

    This means the device was cleared based on substantial equivalence to a predicate device, not on meeting specific performance acceptance criteria through a new study.

    Therefore, I cannot provide the requested information from this document.

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