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

    LAMIN-2 HYDRATING GEL

    K Number: K970153 · Decision Jun 5, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    51
    Registration Numbers
    51
    Same Product Code
    144
    Applicant Total
    9
    Review Days
    140

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    Basic Information

    Device Name
    LAMIN-2 HYDRATING GEL
    K Number
    K970153
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Procyte Corp.
    Date Received
    January 16, 1997
    Decision Date
    June 5, 1997
    Product Code
    MGQ
    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
    MGQ Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic

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    Other Clearances by Procyte Corp.

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    K965143 OSMOCYTE WOUND MANAGER SHEET DRESSING
    K965005 IAMIN IMPREGNATED GAUZE DRESSING
    K964468 IAMIN WET DRESSING (COPPER-SALINE)
    K962623 OSMOCYTE ULTRA/PE PILLOW WOUND DRESSING
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