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

    TRANSORB(TM) ULCER & WOUND DRESSING

    K Number: K922666 · Decision Nov 23, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    292
    Registration Numbers
    292
    Same Product Code
    28
    Applicant Total
    5
    Review Days
    179

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    Basic Information

    Device Name
    TRANSORB(TM) ULCER & WOUND DRESSING
    K Number
    K922666
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4022
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent for Some Indications
    Applicant
    Brady Medical Products Co.
    Date Received
    May 28, 1992
    Decision Date
    November 23, 1992
    Product Code
    NAE
    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
    NAE Dressing, Wound, Hydrogel Without Drug And/Or Biologic

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    Other Clearances by Brady Medical Products Co.

    K Number Device Name
    K945832 BRADY MEDICAL PRODUCTS TRANSCORBENT AND THINSITE TOPICAL BORDER WOUND DRESSINGS
    K941019 BRADY MEDICAL PRODUCTS TRANSORBENTS WOUND DRESSING
    K936052 BRADY MEDICAL PRODUCTS HYSORB(TM) WOUND DRESSING
    K935848 BRADY MEDICAL PRODUCTS TRANSORB WOUND DRESSING