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

    OPRAFLEX

    K Number: K812501 · Decision Oct 2, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    384
    Registration Numbers
    385
    Same Product Code
    702
    Applicant Total
    7
    Review Days
    32

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    Basic Information

    Device Name
    OPRAFLEX
    K Number
    K812501
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Applicant
    Selomas, Inc.
    Date Received
    August 31, 1981
    Decision Date
    October 2, 1981
    Product Code
    FRO
    Advisory Committee
    Unknown
    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
    FRO Dressing, Wound, Drug

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    K821490 SILKAFIX ADHESIVE PLASTER
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