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

    OSMOCYTE ISLAND WOUND DRESSING

    K Number: K972150 · Decision Dec 10, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    79
    Registration Numbers
    79
    Same Product Code
    221
    Applicant Total
    9
    Review Days
    184

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    Basic Information

    Device Name
    OSMOCYTE ISLAND WOUND DRESSING
    K Number
    K972150
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.5090
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent for Some Indications
    Applicant
    Procyte Corp.
    Date Received
    June 9, 1997
    Decision Date
    December 10, 1997
    Product Code
    KMF
    Advisory Committee
    General Hospital
    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
    KMF Bandage, Liquid

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    Other Clearances by Procyte Corp.

    K Number Device Name
    K971612 OSMO/PCA PILLOW WOUND DRESSING
    K972329 OSMOCYTE RA WOUND DRESSING
    K970153 LAMIN-2 HYDRATING GEL
    K965143 OSMOCYTE WOUND MANAGER SHEET DRESSING
    K965005 IAMIN IMPREGNATED GAUZE DRESSING
    K964468 IAMIN WET DRESSING (COPPER-SALINE)
    K962623 OSMOCYTE ULTRA/PE PILLOW WOUND DRESSING
    K953853 IAMIN GEL WOUND DRESSING