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

    SURE-ADAPT NON-ADHERING DRESSING

    K Number: K933966 · Decision Oct 28, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    384
    Registration Numbers
    385
    Same Product Code
    702
    Applicant Total
    6
    Review Days
    73

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    Basic Information

    Device Name
    SURE-ADAPT NON-ADHERING DRESSING
    K Number
    K933966
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent for Some Indications
    Applicant
    Medtrax Industries, Inc.
    Date Received
    August 16, 1993
    Decision Date
    October 28, 1993
    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
    K940694 XEROFORM PETROLATUM DRESSING
    K926207 MEDTRAX PACKING STRIP