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

    XEROFORM PETROLATUM DRESSING

    K Number: K940694 · Decision Mar 30, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    384
    Registration Numbers
    385
    Same Product Code
    702
    Applicant Total
    6
    Review Days
    42

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    Basic Information

    Device Name
    XEROFORM PETROLATUM DRESSING
    K Number
    K940694
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent for Some Indications
    Applicant
    Medtrax Industries, Inc.
    Date Received
    February 16, 1994
    Decision Date
    March 30, 1994
    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 Medtrax Industries, Inc.

    K Number Device Name
    K940692 PLAIN GAUZE DRESSING
    K940691 WET DRESSING
    K940693 PETROLATUM DRESSING
    K933966 SURE-ADAPT NON-ADHERING DRESSING
    K926207 MEDTRAX PACKING STRIP