BEUDAMED
    FDA 510(k) FDA unclassified Substantially Equivalent 🇺🇸 United States

    BIAFINE WOUND DRESSING EMULSION

    K Number: K964240 · Decision Jan 22, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    51
    Registration Numbers
    51
    Same Product Code
    144
    Applicant Total
    1
    Review Days
    90

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    Basic Information

    Device Name
    BIAFINE WOUND DRESSING EMULSION
    K Number
    K964240
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Medix Pharmaceuticals Americas, Inc.
    Date Received
    October 24, 1996
    Decision Date
    January 22, 1997
    Product Code
    MGQ
    Advisory Committee
    Unknown
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    MGQ Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic

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