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

    SORBSAN TOPICAL WOUND DRESSING (MODIFIED)

    K Number: K914575 · Decision Dec 4, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    500
    Registration Numbers
    500
    Same Product Code
    3
    Applicant Total
    1
    Review Days
    50

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    Basic Information

    Device Name
    SORBSAN TOPICAL WOUND DRESSING (MODIFIED)
    K Number
    K914575
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4018
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Dow B. Hickam, Inc.
    Date Received
    October 15, 1991
    Decision Date
    December 4, 1991
    Product Code
    NAC
    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
    NAC Dressing, Wound, Hydrophilic

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