BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    ALLDRESS MULTI LAYERED WOUND DRESSING

    K Number: K910857 · Decision Apr 12, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    570
    Registration Numbers
    570
    Same Product Code
    87
    Applicant Total
    9
    Review Days
    43

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    Basic Information

    Device Name
    ALLDRESS MULTI LAYERED WOUND DRESSING
    K Number
    K910857
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4014
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Scott Health Care
    Date Received
    February 28, 1991
    Decision Date
    April 12, 1991
    Product Code
    NAB
    Advisory Committee
    General, Plastic Surgery
    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
    NAB Gauze / Sponge,Nonresorbable For External Use

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    Other Clearances by Scott Health Care

    K Number Device Name
    K954275 MEPORE PLUS (9X15CM)
    K954274 MEPORE (6X7)
    K945206 ALLDRESS MULTI LAYERED WOUND DRESSING
    K932743 MEFIX(R) ADHESIVE FABRIC FOR DRESSING FIXATION
    K905439 HYPERGEL PROTECTIVE WOUND GEL
    K905438 NORMLGEL PROTECTIVE WOUND GEL
    K900421 PROMISE ABSORBENT PROTECTIVE PAD
    K897142 MESALT STERILE DRESSING