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510(k) Data Aggregation

    K Number
    K962917
    Device Name
    MULTIDEX HYDROPHILIC WOUND DRESSING GEL
    Date Cleared
    1996-12-16

    (143 days)

    Product Code
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    LANGE MEDICAL PRODUCTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    MULTIDEX* Gel in a multi-use container is indicated for the management of stage II, III, IV pressure sores/ulcers, venous stasis ulcers, varicose ulcers, ischemic arterial ulcers, diabetic ulcers, neuropathic ulcers, poorly healing non-neoplastic wounds/ulcers and wounds/ulcers due to trauma. These are the identical indications as the predicate device.
    Device Description
    MULTIDEX* (polyglucose) Gel contains 66.9 percent Maltodextrin NF, one percent Ascorbic Acid, USP, 10 percent glycerin USP, 22 percent Purified Water USP, and 0.1 percent sorbic acid in a multi-use container. MULTIDEX Gel in a multi-use container contains the same ingredients as the predicate device with the addition of 0.1 percent sorbic acid as a preservative. It is packaged in a 90 gram low density polyethylene tube.
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    K Number
    K955399
    Device Name
    MULTIDEX PLUS HYDROPHILIC WOUND DRESSING
    Date Cleared
    1996-02-07

    (75 days)

    Product Code
    Regulation Number
    880.5090
    Why did this record match?
    Applicant Name (Manufacturer) :

    LANGE MEDICAL PRODUCTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Device Description
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