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

    WOUND DRESSING/ABD PAD, MODEL #10810

    K Number: K990861 · Decision Apr 12, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    502
    Registration Numbers
    502
    Same Product Code
    106
    Applicant Total
    7
    Review Days
    27

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    Basic Information

    Device Name
    WOUND DRESSING/ABD PAD, MODEL #10810
    K Number
    K990861
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4020
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Hospital Specialty Co.
    Date Received
    March 16, 1999
    Decision Date
    April 12, 1999
    Product Code
    NAD
    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
    NAD Dressing, Wound, Occlusive

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