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

    BIOFILM TRANS. ISLAND, ISLAND ULCER & WOUND DRESS.

    K Number: K872099 · Decision Jun 30, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    502
    Registration Numbers
    502
    Same Product Code
    106
    Applicant Total
    4
    Review Days
    29

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    Basic Information

    Device Name
    BIOFILM TRANS. ISLAND, ISLAND ULCER & WOUND DRESS.
    K Number
    K872099
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4020
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent for Some Indications
    Applicant
    The Bfgoodrich Co.
    Date Received
    June 1, 1987
    Decision Date
    June 30, 1987
    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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    Other Clearances by The Bfgoodrich Co.

    K Number Device Name
    K875253 BFGOODRICH BIOTHANE NON-ADHERENT DRESSING
    K872100 BIOFILM TRANSORBENT ULCER AND WOUND DRESSING
    K872101 BIOFILM TRANS. POUCH ULCER & WOUND DRESSING