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

    BIOLEX WOUND GEL,

    K Number: K920050 · Decision Apr 7, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    60
    Registration Numbers
    60
    Same Product Code
    146
    Applicant Total
    5
    Review Days
    92

    Basic Information

    Device Name
    BIOLEX WOUND GEL,
    K Number
    K920050
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent for Some Indications
    Applicant
    CATALINA BIOMEDICAL CORP.
    Date Received
    January 6, 1992
    Decision Date
    April 7, 1992
    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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