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

    OSMOCYTE ULTRA/PE PILLOW WOUND DRESSING

    K Number: K962623 · Decision Nov 26, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    79
    Registration Numbers
    79
    Same Product Code
    221
    Applicant Total
    9
    Review Days
    144

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    Basic Information

    Device Name
    OSMOCYTE ULTRA/PE PILLOW WOUND DRESSING
    K Number
    K962623
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.5090
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Procyte Corp.
    Date Received
    July 5, 1996
    Decision Date
    November 26, 1996
    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
    K972150 OSMOCYTE ISLAND WOUND DRESSING
    K970153 LAMIN-2 HYDRATING GEL
    K965143 OSMOCYTE WOUND MANAGER SHEET DRESSING
    K965005 IAMIN IMPREGNATED GAUZE DRESSING
    K964468 IAMIN WET DRESSING (COPPER-SALINE)
    K953853 IAMIN GEL WOUND DRESSING