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

    BIOBRANE BRAND TEMPORARY WOUND-DRESSING

    K Number: K801635 · Decision Aug 4, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    384
    Registration Numbers
    385
    Same Product Code
    702
    Applicant Total
    2
    Review Days
    20

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    Basic Information

    Device Name
    BIOBRANE BRAND TEMPORARY WOUND-DRESSING
    K Number
    K801635
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Applicant
    Hall-Woodroof, Inc.
    Date Received
    July 15, 1980
    Decision Date
    August 4, 1980
    Product Code
    FRO
    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
    FRO Dressing, Wound, Drug

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    Other Clearances by Hall-Woodroof, Inc.

    K Number Device Name
    K791184 BIOBRANE BRAND TEMPORARY WOUND DRESSING