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

    SELOPOR

    K Number: K821258 · Decision Aug 19, 1982
    View on FDA
    Classifications
    1
    FEI Numbers
    384
    Registration Numbers
    385
    Same Product Code
    702
    Applicant Total
    7
    Review Days
    111

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    Basic Information

    Device Name
    SELOPOR
    K Number
    K821258
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Applicant
    Selomas, Inc.
    Date Received
    April 30, 1982
    Decision Date
    August 19, 1982
    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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    Other Clearances by Selomas, Inc.

    K Number Device Name
    K861215 GAUZE SPONGES USP TYPE VII
    K821260 VITOFIT
    K821259 VITASAN
    K821490 SILKAFIX ADHESIVE PLASTER
    K821257 SELOFIX
    K812501 OPRAFLEX