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

    SORBEX(TM) SOFT SPONGE

    K Number: K895654 · Decision Feb 20, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    502
    Registration Numbers
    502
    Same Product Code
    106
    Applicant Total
    2
    Review Days
    153

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    Basic Information

    Device Name
    SORBEX(TM) SOFT SPONGE
    K Number
    K895654
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4020
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent for Some Indications
    Applicant
    Fountain Pharmaceuticals, Inc.
    Date Received
    September 20, 1989
    Decision Date
    February 20, 1990
    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 Fountain Pharmaceuticals, Inc.

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