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

    IODOSORB GEL

    K Number: K905069 · Decision Jan 31, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    15
    Registration Numbers
    15
    Same Product Code
    21
    Applicant Total
    2
    Review Days
    83

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    Basic Information

    Device Name
    IODOSORB GEL
    K Number
    K905069
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4018
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Perstorp AB C/O Robert Joel Slomoff
    Date Received
    November 9, 1990
    Decision Date
    January 31, 1991
    Product Code
    KOZ
    Advisory Committee
    General, Plastic Surgery
    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
    KOZ Beads, Hydrophilic, For Wound Exudate Absorption

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    Other Clearances by Perstorp AB C/O Robert Joel Slomoff

    K Number Device Name
    K870559 IODOSORB POWDER