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

    COVERSAN, ISLESAN

    K Number: K952547 · Decision Aug 14, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    79
    Registration Numbers
    79
    Same Product Code
    221
    Applicant Total
    2
    Review Days
    73

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    Basic Information

    Device Name
    COVERSAN, ISLESAN
    K Number
    K952547
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.5090
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Medical Device Development Co.
    Date Received
    June 2, 1995
    Decision Date
    August 14, 1995
    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 Medical Device Development Co.

    K Number Device Name
    K952449 TRANSAN, TRANSPARENT FILM DRESSING, TRANSPARENT WOUND DRSSING