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

    ALBA HEALTH CARE NON-ADHERING DRESSING

    K Number: K850241 · Decision Mar 12, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    384
    Registration Numbers
    385
    Same Product Code
    702
    Applicant Total
    8
    Review Days
    49

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    Basic Information

    Device Name
    ALBA HEALTH CARE NON-ADHERING DRESSING
    K Number
    K850241
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Applicant
    Alba Health Care
    Date Received
    January 22, 1985
    Decision Date
    March 12, 1985
    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 Alba Health Care

    K Number Device Name
    K864689 ALBA HEALTH CARE IODOFORM PACKING STRIP
    K861154 ALBA HEALTH CARE PLAIN PACKING STRIP
    K851918 INFANT PHOTOTHERAPY MASK
    K850881 ALBA DRY BURN PAD
    K850904 ALBA DRY BURN DRESSING
    K812904 STERILE ORTHOPEDIC STOCKINETTE
    K803171 PROCEDURE & RECOVERY PATIENT SUIT