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

    MESALT STERILE DRESSING

    K Number: K897142 · Decision Mar 27, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    384
    Registration Numbers
    385
    Same Product Code
    702
    Applicant Total
    9
    Review Days
    90

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    Basic Information

    Device Name
    MESALT STERILE DRESSING
    K Number
    K897142
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Applicant
    Scott Health Care
    Date Received
    December 27, 1989
    Decision Date
    March 27, 1990
    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 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
    K910857 ALLDRESS MULTI LAYERED WOUND DRESSING
    K905438 NORMLGEL PROTECTIVE WOUND GEL
    K900421 PROMISE ABSORBENT PROTECTIVE PAD